MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ASR XL TAP SLV ADAP 9/10+3; ASR HIP SYSTEM : HIP FEMORAL SLEEVE

Catalog Number 999800303

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

Patient Problems Pain (1994); No Code Available (3191)

Event Date 02/10/2020

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 revision: asr resurfacing (left).Reason(s) for revision: pain.Doi: (b)(6) 2005.Dor: (b)(6) 2020; (left 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undertaken, as there is an ongoing investigation regarding the root cause(s) and/or corrective actions.Ref.Wwcapa 00780 superseded by mdd capa-001226.

• Brand Name: ASR XL TAP SLV ADAP 9/10+3
• Type of Device: ASR HIP SYSTEM : HIP FEMORAL SLEEVE
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 10110030
• MDR Text Key: 193407952
• Report Number: 1818910-2020-13009
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 999800303
• Device Lot Number: 1221361
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Treatment: AML A PLUS 12.0 MM; ASR ACETABULAR IMPLANT 46; ASR XL TAP SLV ADAP 9/10+3; UNKNOWN HIP FEMORAL HEAD; AML A PLUS 12.0 MM; ASR ACETABULAR IMPLANT 46; ASR XL TAP SLV ADAP 9/10+3; UNKNOWN HIP FEMORAL HEAD
• Patient Outcome(s): Required Intervention