AW Burns

Christoph E Heyde

J Amoore

JJ Hayes

Johannes K Fakler

LD Dorr

LI Havelin

P Herberts

P Soderman

S Kurtz

Thilo John

TJ Blumenfeld

Yohan Robinson

English

PubMed

John Thilo

Heyde Christoph E

Robinson Yohan

Fakler Johannes K

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Patient Safety in Surgery

Errors in handling and manufacturing of orthopaedic implants: the tip of the iceberg of an unrecognized system problem?

Springer - Publisher Connector

Fakler, Johannes K

Robinson, Yohan

Heyde, Christoph E

John, Thilo

Publikationer från Uppsala Universitet

Errors in handling and manufacturing of orthopaedic implants : the tip of the iceberg of an unrecognized system problem?

Robinson, Yohan,

Swepub

Name not available

Errors in handling and manufacturing of orthopaedic implants [Elektronisk resurs] : the tip of the iceberg of an unrecognized system problem?

Crossref

BioMed CentralPatient Safety in SurgeryssOpen AcceEditorialErrors in handling and manufacturing of orthopaedic implants: the tip of the iceberg of an unrecognized system problem?Johannes K Fakler*, Yohan Robinson, Christoph E Heyde and Thilo JohnAddress: Department of Trauma and Reconstructive Surgery, Charité University Medical School, Campus Benjamin Franklin, Hindenburgdamm 30, 12200 Berlin, GermanyEmail: Johannes K Fakler* - johannes.fakler@charite.de; Yohan Robinson - yohan.robinson@charite.de; Christoph E Heyde - christoph.heyde@charite.de; Thilo John - thilo.john@charite.de* Corresponding author    Patient safety related to orthopaedic implants, particularlyjoint arthroplasty, is a major concern due to the increasingelderly population and the wide variety of availabledevices. The safe use of medical devices, such as orthopae-dic implants, is regulated by institutions or governmentalagencies in many countries. Nevertheless, adverse inci-dents associated with the implantation of orthopaedicdevices in patients are reported periodically in the newsmedia.Recently, a series of 47 consecutive patients with falselyimplanted total knee arthroplasties was reported in Ger-man newspapers [1-5]. Between May 2006 and March2007, orthopaedic surgeons in a German hospital errone-ously implanted femoral components for total kneereplacements in a non-cemented fashion, although thesespecific implants had been designed for cemented useonly [1-5]. Apparently, multiple contributing factorsaccounted for these adverse events in which patients wereharmed by a combination of human failure and systemerrors. Until present, 30 patients underwent a surgicalrevision, four patients have been scheduled for revisionsurgery, and the remaining 13 patients have not reportedany complaints [6].The disputed US-manufactured knee prosthesis is availa-ble in two different versions, for use with or withoutcement. This specific implant was introduced at thereported hospital in May 2006. A root cause analysisrevealed that one of the contributing factors leading towrong use of this implant was related to the original pack-age labeled in English language. The labeling of the femo-ral component packaging as "non-modular cemented"was erroneously translated to "non-cemented" or "with-out cement" by the responsible hospital staff [1-4]. Withrespect to the German law on medical products, alldevices must be delivered with an according Germaninstruction [7]. In the present case, the US manufacturerof the knee prosthesis included a German instructioninside the package [2]. About one year later, a sticker withthe German translation of "without cement" was added tothe package labeling of the "true" cementless version. Atthe time, the responsible hospital staff suddenly realizedthat some femoral components designed for cementeduse had been erroneously implanted in a cementless fash-ion [3].Aside from this system error related to wrong languagetranslation and interpretation, another contributing fac-tor which led to the wrong use of this orthopaedic devicemight have been a misinformed representative by themanufacturing company who was present in the operat-ing room at the time of surgery. According to the hospi-tal's spokesperson, the components for cemented use onlywere sorted into the shelves designated for cementlesscomponents despite continuing supervision by the com-pany's representative. Apparently, this particular repre-sentative attended knee arthroplasty procedures at thishospital and assisted the operative surgeons in technicalissues related to this newly introduced implant [1,3].Published: 5 December 2007Patient Safety in Surgery 2007, 1:5 doi:10.1186/1754-9493-1-5Received: 24 October 2007Accepted: 5 December 2007This article is available from: http://www.pssjournal.com/content/1/1/5© 2007 Fakler et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.Page 1 of 3(page number not for citation purposes)Patient Safety in Surgery 2007, 1:5 http://www.pssjournal.com/content/1/1/5According to the US manufacturer, no serious adverseevents or technical problems have been reported within15 years of distribution in Germany. No comments weremade related to the potential aspect of an individualhuman failure by the company's representative [1,3].The shocking fact that 47 consecutive patients sufferedfrom the same basic error implies that not only humanfailure, but also system errors and lacking control mecha-nisms may have contributed to this series of adverseevents.As outlined by this alarming example, most adverse eventsin medical or surgical procedures are typically of multifac-torial origin. This includes organisational and structuralmismanagement which may be accentuated by unpredict-able individual human failure [10]. A root cause analysisof the above-mentioned case scenario should help toimprove patient safety related to the improper handling oforthopaedic implants in the future.Analogous to the Food and Drug Administration (FDA) inthe USA, the Federal Institute for Drugs and MedicalDevices in Germany regulates the use of any medicaldevice that is intended for use in the diagnosis, mitiga-tion, treatment, or prevention of disease [7,11]. The FDAregulations ascertain that all labeling of medical productsmust be in English language [12]. The terms "label" and"labeling" are specifically defined as "display of written,printed, or graphic matter upon the immediate containerof any article..." and "all labels and other written, printed,or graphic matter upon any article or any of its containersor wrappers..." [12]. The German law regulating the use ofmedical devices demands that product information, par-ticularly safety issues, are provided in German language.However, this regulation does not specifically demandthat labeling of packaging of medical devices must be inGerman language [7]. As outlined in the present case, theEnglish language package labeling of an arthroplastyimplant was the basis of a wrong translation/interpreta-tion of the label and thus led to an improper implantationof total knees. From a human failure perspective, the dis-tinct coating properties between the cemented and unce-mented version of the femoral component (porous vs.smooth surface) were neither recognized by the instru-menting personnel, nor by the responsible surgeon at thetime of surgery [1,3,4].Another aspect to be addressed is the role of the presenceof a health care industry representative (HCIR) in theoperating room. According to the American College ofSurgeons (ACS), industry representatives in clinical set-tings are assigned an important role in patient safety andquality of care by providing detailed information aboutthe proper use of medical devices [13]. However, the sur-geon in charge – as the "captain of the ship" – remainsultimately responsible for the adequate performance ofsurgical procedures [13,14]. On the other hand, compa-nies manufacturing medical devices must take adequatesteps to ensure a proper education and instruction of theirrepresentatives. This was obviously not warranted in thepresent case. With respect to the protection of patients'rights and privacy, we also question why patients'informed consent is not required for the presence of thirdparties in the operating room, such as HCIRs.The establishment of regional, national, or internationalreporting systems and quality control registries may helpavoiding repeated identical error patterns, e.g. by earlydetection of a discrepancy between type of implant andthe implanting procedure. The Swedish Hip Registry hasbeen established for many years now and directly influ-enced the number and types of available hip implants byeliminating those with poor performance [15]. Althoughthese consequences result from long-term data, the Nor-wegian hip registry successfully demonstrated detection ofpoor cement quality and subsequent recall at an earlystage [16].Since the introduction of the Swedish hip registry in 1979,revision rates for hip arthroplasty have been reducedapproximately by half, to currently 7% [15,17,18]. In con-trast, the mean revision rate for total hip arthroplasty inthe USA is still as high as 18% [18,19]. It is conceivablethat formal registries on joint arthroplasties may helpidentifying implantation-related errors at an early stageand thus prevent further patients from undergoing inade-quate surgical procedures.We wish to emphasize that the particular incidence ana-lyzed here, based on a rare event which occurred in a sin-gle German hospital, but may reflect the "tip of theiceberg" of an unrecognized risk for patient safety in jointarthroplasty. This notion is exemplified by the world-widerecall of the Interop acetabular cup by Sulzer Orthopedics(Austin, TX) due to a manufacturing error in 2001. Thiserror was attributed to a modified cleaning process, whichleft oily residues on the implant's porous coating [8]. Dur-ing the time of introduction of this acetabular cup in 1997and its worldwide recall in 2001, the device had beenimplanted in about 17,500 patients. By 2005, about 2,500patients had undergone revision surgeries due to the mal-fabricated cup [9]. A retrospective study reported a failurerate of 30% for the Interop shell within two to 17 monthsafter total hip arthroplasty [9].The high number of adversely affected patients in thisexample demonstrates that the identification and correc-tion of manufacturing errors in joint implants may takeseveral months to years. Obviously, in times of a globalPage 2 of 3(page number not for citation purposes)Patient Safety in Surgery 2007, 1:5 http://www.pssjournal.com/content/1/1/5Publish with BioMed Central   and  every scientist can read your work free of charge"BioMed Central will be the most significant development for disseminating the results of biomedical research in our lifetime."Sir Paul Nurse, Cancer Research UKYour research papers will be:available free of charge to the entire biomedical communitypeer reviewed and published immediately upon acceptancecited in PubMed and archived on PubMed Central yours — you keep the copyrightSubmit your manuscript here:http://www.biomedcentral.com/info/publishing_adv.aspBioMedcentralmarket with worldwide product distribution, any ortho-paedic device may be implanted in hundreds or thou-sands of patients within a very short period of time. Thisexample emphasizes the need for a systematic approachfor implementation of an "early warning system" in orderto improve patient safety.In summary, patient safety in the context of routinely andfrequently performed surgical procedures, such as totaljoint replacement, needs to be improved in a systematicfashion. In the case related to wrong translation of prod-uct labels, the unequivocal labeling should be mandatoryfor all product containers and wrappings in the languageof the country where the implant is used.With respect to the role of HCIRs, surgical departmentadministrators should establish specific written policiesgoverning the presence of third parties in the operatingroom. The surgeon remains ultimately responsible forcorrect use of orthopaedic implants and must be familiarwith all specific details of instrumentation and implanta-tion techniques. In the case where a surgeon uses animplant for the first time, we recommend a prior on tabledemonstration and training of correct implant handlingby an HCIR. Patients should furthermore be informedabout the presence of HCRIs in the operating room andprovide a written informed consent for allowing non-medical third parties in the operating room.The last column in patient safety with respect to orthopae-dic implants addresses public institutions which supervisemedical products and patient concerns. With regard tojoint arthroplasty, studies have shown that formal regis-tries can improve long-term patient safety by reducingcomplication and revision rates significantly [12-15].Such registries must be designed in a way that allows anearly identification of errors and failures, in order to avoidrepetitive errors which may consecutively affect a largepatient population.Competing interestsThe author(s) declare that they have no competing inter-ests.References1. Klinikskandal: Wer hat Schuld?   [http://www.morgenpost.de/content/2007/08/15/berlin/915886.html]2. Anzeige gegen St. Hedwig und Hersteller   [http://www.welt.de/berlin/article1108814/Anzeige_gegeb_St._Hedwig_und_Hersteller_.html]3. Senat fordert Warnsystem für Kliniken   [http://www.tagesspiegel.de/berlin/Kliniken-Hueftgelenke;art270,2358117]4. Knieprothesen sind kaum zu verwechseln   [http://www.tagesspiegel.de/berlin/Prothesenskandal;art270,2359347]5. OP-Skandal auch in anderen Kliniken?   [http://www.morgenpost.de/content/2007/08/18/berlin/916463.html]6. 30 Patienten haben eine neue Knie-Prothese   [http://www.morgenpost.de/content/2007/09/01/berlin/919021.html]7. Gesetz über Medizinprodukte (Medizinproduktegesetz –MPG)   [http://www.gesetze-im-internet.de/bundesrecht/mpg/gesamt.pdf]8. Dorr LD, Sirianni L, OPA-C : The risk of product liability: ortho-pedic surgeons can be trapped.  Clin Ortho Relat Res 2003,407:50-53.9. Blumenfeld TJ, Bargar WL: Early aseptic loosening of a modernacetabular component secondary to a change in manufac-turing.  J Arthroplasty 2005, 21:689-695.10. Amoore J, Ingram P: Quality improvement report: Learningfrom adverse incidents involving medical devices.  BMJ 2002,325:272-275.11. Is the Product a Medical Device?   [http://www.fda.gov/cdrh/devadvice/312.html]12. Labeling requirements   [http://www.fda.gov/cdrh/devadvice/33.html]13. Guidelines for collaboration of industry and surgical organi-zations in support of research and continuing education[http://www.fasc.org/fellows_info/statements/st-36.html]14. Hayes JJ: The role of industry in the implantation and follow-up of devices: a practitioner's perspective.  Card ElectrophysiolRev 2003, 7:58-59.15. Herberts P, Malchau H: Long-term registration has improvedthe quality of hip replacement.  Acta Orthop Scand 2000,71:111-121.16. Havelin LI, Engesaeter LB, Espehaug B, Furnes O, Stein AL, Vollset SE:The Norwegian Arthroplasty Register.  Acta Orthop Scand 2000,71:337-353.17. Soderman P, Malchau H, Herberts P, Zugner R, Regner H, GarellickG: Outcome after total hip arthroplasty.  Acta Orthop Scand2001, 72:113-119.18. Burns AW, Bourne RB: Economics of total hip arthroplasty.Current Orthopedics 2006, 20:203-207.19. Kurtz S, Mowat F, Ong K, Chan N, Lau E, Halpern M: Prevalence ofprimary and revision total hip and knee arthroplasty in theUnited States from 1990 through 2002.  J Bone Joint Surg Am2005, 87:1487-97.Page 3 of 3(page number not for citation purposes)

Digitala Vetenskapliga Arkivet - Academic Archive On-line

30 Patienten haben eine neue Knie-Prothese [ h t t p : /

Bargar WL: Early aseptic loosening of a modern acetabular component secondary to a change in manufacturing.

Garellick G: Outcome after total hip arthroplasty. Acta Orthop Scand

Gesetz über Medizinprodukte (Medizinproduktegesetz – MPG)

Guidelines for collaboration of industry and surgical organizations in support of research and continuing education [http://www.fasc.org/fellows_info/statements/st-36.html]

Is the Product a Medical Device?

Klinikskandal: Wer hat Schuld?

Knieprothesen sind kaum zu verwechseln [ h t t p : /

Malchau H: Long-term registration has improved the quality of hip replacement. Acta Orthop Scand

OP-Skandal auch in anderen Kliniken?

OPA-C : The risk of product liability: orthopedic surgeons can be trapped. Clin Ortho Relat Res

Prevalence of primary and revision total hip and knee arthroplasty in the United States from

Quality improvement report: Learning from adverse incidents involving medical devices. BMJ

RB: Economics of total hip arthroplasty. Current Orthopedics

Senat fordert Warnsystem für Kliniken

The role of industry in the implantation and followup of devices: a practitioner's perspective. Card Electrophysiol Rev

Vollset SE: The Norwegian Arthroplasty Register. Acta Orthop Scand

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Errors in handling and manufacturing of orthopaedic implants: the tip of the iceberg of an unrecognized system problem?

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