The literature article entitled, "revision of failed metal-on-metal total hip arthroplasty: midterm outcomes of 203 consecutive cases" written by david a.Crawford, md, joanne b.Adams, bfa, cmi, michael j.Morris, md, keith r.Berend, md, and adolph v.Lombardi jr., md, facs published by the journal of arthroplasty published online 13 april 2019 was reviewed.The article's purpose was to report on midterm outcomes of 203 revisions for failed metal-on-metal total hip arthroplasties.The article provides table 1 with a list of depuy and non-depuy products that were revised (203 total).It is noted that depuy had 13 asr and 10 ultamet cases out of the 203 total revisions.Cement manufacturer was not identified.Table 2 provides original revision reasons but does not specify which revision reason are associated with depuy products.Therefore, accurate quantities cannot be determined based upon information provided by article.The article also reports that 28 cases with patient identifiers (table 4) required re-revision and the reasons but does not provide the details of what implants were utilized during revision or re-revision.Cross reference and narrative descriptions also do not provide adequate information to capture the identified patients.This pc will only capture the original identified depuy products that were revised for unspecified listed reasons.If further information is provided, this pc will be updated and the appropriate reports will be filed.Figure 1 provides radiographic images of a revised mom without product or patient identification that required a re-revision.Depuy products: asr head, asr cup, asr augment, unknown stem, metal head, ultamet liner, pinnacle cup.Revision reasons: adverse reaction to metal debris.Acetabular aseptic loosening.Infection.Femoral aseptic loosening.Dislocation.Fracture (article indicates fractures were periprosthetic femoral).Cup malposition.
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Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive. depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.H10 additional narrative: added: h7, h9.
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