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 Foreign Body Reaction (1868); No Code Available (3191)

Event Date 10/01/2019

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, "preliminary report of clinical experience with metal-on-highly-crosslinked polyethylene hip resurfacing" written by r.B.C.Treacy, j.P.Holland, j.Daniel, h.Ziaee, and d.J.W.Mcminn published by bone and joint research october 2019 was reviewed.The article's purpose was to report early performance of hra (hip resurfacing arthroplasty) using a direct-to-bone cementless mono-block xlpe component (non de-puy) with a cobalt-chrome femoral head (non-depuy).The article's focus is on non-depuy component performances.However, the article mentions one of the cases includes a revision case where the non-depuy components replaced a failed depuy asr hra and the reason for revision was for adverse reaction to metal debris.This complaint captures this one revision case.Figure 7a provides radiographic image of the asr component that was revised to a non-depuy product (7b and 7c) in a (b)(6) year old very active male patient.Depuy products: asr head, asr cup.Adverse event: revision for armd (attributed to bearing wear).

Manufacturer Narrative

Product complaint # (b)(4).Corrected g3- sales rep was incorrectly reported on initial.

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: 10308572
• MDR Text Key: 201858448
• Report Number: 1818910-2020-16524
• 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
• Type of Report: Initial,Followup,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?: Yes
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention