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

Catalog Number UNK HIP FEMORAL HEAD

Device Problem Naturally Worn (2988)

Patient Problems Test Result (2695); No Code Available (3191)

Event Date 05/07/2018

Event Type  malfunction  

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, "femoral offset found not to affect metal ion levels in metal-on-metal total hip arthroplasty" written by eoghan pomeroy, fergal macnamara, evelyn murphy, niall mcgoldrick, anant mahapatra, and nasir awan published by irish journal of medical science published online on 7 may 2018 was reviewed.The article's main purpose was to investigate the relationship between femoral offset and wear by measuring circulating metal ion levels in mom (metal-on-metal) in tha (total hip arthroplasty.Data was compiled from 95 patients (68 males and 27 females) with mean age of 64.9 years at time of surgery and all were implanted with depuy asr xl system implanted between december 2005 and august 2010.Femoral stem was not identified.The article does not report if any of the patients were revised or experienced any adverse symptoms.The article only reports the findings were elevated ion levels (attributed to bearing wear).The article did not report any statistically significant correlation between femoral offset groups and chromium ion levels.Depuy products: asr xl head, asr xl cup, asr xl sleeve (augment).Adverse events: elevated ion levels attributed to bearing wear.

Manufacturer Narrative

Product complaint # : (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 10306326
• MDR Text Key: 200882589
• Report Number: 1818910-2020-16488
• 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: company representative,foreig
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1