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

Event Date 04/16/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).No 510(k) number provided because this implant is sold internationally with different indications for use; it is currently sold in the us under a different part number.The correction/removal reporting number listed applies to the corresponding product code sold domestically.(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, "ultrasound-based decision making following metal-on-metal hip arthroplasty" written by remo goderecci, andrea fidanza, stefano necozione, vincenzo francione, pier francesco indelli, and vittorio calvisi published by journal of clinical orthopaedics and trauma made available online 16 april 2019 was reviewed.The article's purpose is to determine the association between metal ions blood levels and the amount and quality of the periprosthetic fluid collection detected during ultrasound investigation.Data was compiled from 116 patients (56 males and 60 females) with age range of 15-86 years.All patients received depuy asr xl mom thas (123 total thas) between 2006 and 2009.The article does not identify the femoral stems utilized with the asr xl construct.Fifty patients (51 implants) underwent revision with range of 1.79-9.26 years from primary implantation.The article relates any findings of armd (adverse reaction to metal debris), altr (adverse local tissue reactions), and alval (aseptic lymphocyte-dominated vasculitis-associated lesions) to the release of co (cobalt) and cr (chromium) from the metal-on-metal bearing surface.The use of the ultrasound was to detect clinically significant altrs.Co and cr blood tests were performed by the laboratory of clinical chemistry at charing cross hospital (london, england), and the results were categorized according to the italian society for orthopaedics and traumatology's guidelines.This complaint captures the associated adverse events.Depuy products: asr xl cup, asr xl femoral head, asr xl femoral sleeve (augment).Reasons for revision: elevated ion levels.Pseudotumor.Altr.

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 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: 10291614
• MDR Text Key: 200443576
• Report Number: 1818910-2020-16196
• 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: foreign,health professional,l
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• 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
• 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
• Patient Outcome(s): Required Intervention