MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNKNOWN HIP FEMORAL AUGMENT

Catalog Number UNK HIP FEMORAL AUGMENT

Device Problems Nonstandard Device (1420); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); No Code Available (3191)

Event Date 04/13/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.[(b)(4)].

Event Description

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.

Manufacturer Narrative

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.

• Brand Name: UNKNOWN HIP FEMORAL AUGMENT
• Type of Device: HIP FEMORAL AUGMENT
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 10074212
• MDR Text Key: 191532617
• Report Number: 1818910-2020-12274
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL AUGMENT
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/13/2020
• Initial Date FDA Received: 05/20/2020
• Supplement Dates Manufacturer Received: 07/10/2020
• Supplement Dates FDA Received: 07/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention