MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ASR ACETABULAR IMPLANT 50; ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number 999804550

Device Problem Malposition of Device (2616)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Tissue Damage (2104); No Code Available (3191)

Event Date 07/24/2012

Event Type  Injury  

Manufacturer Narrative

(b)(4).Occupation: lawyer.Follow-up is being conducted to determine initial reporter contact information.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

Asr surgeon confirmation form and medical records received.Scf alleges component malalignment, alval and soft tissue reaction.After review of the medical records the patient was revised to address pain, alval, metallosis and synovitis.Operative findings reported alval, metallosis, synovitis, minor corrosion at trunion and consistent acetabular retroversion.Doi: (b)(6) 2008; dor: (b)(6) 2012; left hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary - the asr platform was voluntarily recalled from the market in (b)(6) 2010, and the asr product codes are now considered inactive.Further investigation of this individual incident will not be undertaken.The investigation regarding the root cause(s) and/or corrective actions was conducted under mdd capa(b)(4).Ongoing post market surveillance is conducted per our procedures for this product.

• Brand Name: ASR ACETABULAR IMPLANT 50
• Type of Device: ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 10536061
• MDR Text Key: 207014705
• Report Number: 1818910-2020-20088
• 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,other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 999804550
• Device Lot Number: 2475411
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/30/2020
• 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 50.; CORAIL2 STD SIZE 8.; DEPUY ASR XL FEM IMP SIZE 45.; LARGE MOD HEAD ADAPT 12/14 +5.; ASR ACETABULAR IMPLANT 50; CORAIL2 STD SIZE 8; DEPUY ASR XL FEM IMP SIZE 45; LARGE MOD HEAD ADAPT 12/14 +5
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR