MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 TOTAL ASR FEM IMP SIZE 46; ASR HIP SYSTEM : HIP METAL FEMORAL HEADS

Catalog Number 999803946

Device Problem Noise, Audible (3273)

Patient Problems Pain (1994); Test Result (2695); No Code Available (3191)

Event Date 05/18/2011

Event Type  Injury  

Manufacturer Narrative

(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

Asr resuracing surgeon confirmation form and claimsute alerts record received.Scf alleges pain, noise and elevated metal ions.Doi: (b)(6) 2007 - dor: (b)(6) 2011 (right hip).

Manufacturer Narrative

Product complaint # : (b)(4).Investigation summary : the asr platform was voluntarily recalled from the market in august 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-001226.Ongoing post market surveillance is conducted per our procedures for this product.

• Brand Name: TOTAL ASR FEM IMP SIZE 46
• Type of Device: ASR HIP SYSTEM : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 10283674
• MDR Text Key: 199101653
• Report Number: 1818910-2020-16059
• 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,foreig
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 07/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 999803946
• Device Lot Number: 2299815
• 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
• Treatment: ASR ACETABULAR IMPLANT 52; TOTAL ASR FEM IMP SIZE 46; ASR ACETABULAR IMPLANT 52; TOTAL ASR FEM IMP SIZE 46
• Patient Outcome(s): Required Intervention