MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNK HIP FEMORAL HEAD METAL ASR; METAL FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD METAL ASR

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Insufficient Information (4580)

Event Date 12/11/2018

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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The literature article entitled, "a new classification for proximal femur bone defects in conservative hip arthroplasty revisions" written by filippo casella, fabio favetti, gabriele panegrossi, matteo papalia, and francesco falez published by international orthopaedics published online on 11 december 2018 was reviewed.The article's purpose is to report an analysis of femoral changes observed during revision procedures of conservative components, with the aim of proposing a practical classification to select reconstructive options.Data was compiled from 21 consecutive revision procedures involving conservative hip arthroplasty that were performed between october 2005 and february 2018.Five resurfacing hip femoral implants were depuy asr listed amongst competitor products that were also retrieved from other patients.The article does not specify which adverse events are related to specific products.Cement manufacturer is not identified.This complaint captures adverse events that are possibly related to depuy implants.Non-depuy products were utilized for revision procedures to replace any depuy implants.The article reports that the resurfacing implants were revised for loosening but does not identify interface or anatomical location.Figure 2 provides radiographic image of an unidentified resurfaced hip being revised for aseptic loosening (interface or anatomical location not provided).Figure 3 provides radiographic image of an unidentified resurfaced hip noted to be a failure but no further information provided.Figure 4 provides radiographic image of an unidentified resurfaced hip with a femoral neck fracture.Figure 5-9 provide radiographic images of non-depuy products.Depuy product: asr resurfacing head, asr resurfacing cup adverse event: loosening treated by revision.

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: UNK HIP FEMORAL HEAD METAL ASR
• Type of Device: METAL FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 11012421
• MDR Text Key: 221799939
• Report Number: 1818910-2020-26983
• Device Sequence Number: 1
• Product Code: KWA
• 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: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• 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 METAL ASR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/13/2021
• 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