MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ASR UNI FEMORAL IMPL SIZE 45; HIP FEMORAL HEAD

Catalog Number 999800145

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/01/2020

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.

Event Description

Asr revision for groin pain and elevated ion levels.Right hip, original surgery 2008.

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.Device history lot: previous investigations that have included device history reviews (mre) since the asr platform was launched have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.Mre not requested.

• Brand Name: ASR UNI FEMORAL IMPL SIZE 45
• 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: 11087671
• MDR Text Key: 224096616
• Report Number: 1818910-2020-27746
• 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: company representative,health
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/11/2020

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: 999800145
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/11/2020
• Initial Date FDA Received: 12/29/2020
• Supplement Dates Manufacturer Received: 01/25/2021
• Supplement Dates FDA Received: 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Treatment: ASR ACETABULAR IMPLANT 52; UNK HIP FEMORAL SLEEVE ASR; UNKNOWN HIP FEMORAL STEM; ASR ACETABULAR IMPLANT 52; UNK HIP FEMORAL SLEEVE ASR; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 67