MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 DEPUY ASR XL FEM IMP SIZE 51; ASR HIP SYSTEM : HIP METAL FEMORAL HEADS

Catalog Number 999890151

Device Problems Nonstandard Device (1420); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 05/25/2011

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.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.

Event Description

New ecm record created in order to update legacy complaint (b)(4).Asr revision to take place (b)(6) 2012.Asr xl acetabular system (left).Reason(s) for revision: alval/soft tissue reaction.Update ad 26 jul 2019: dint (b)(4) has been reopened under (b)(4) due to receipt of surgeon confirmation form indicating that the patient was revised to address pain and alval/soft tissue reaction.Added patient initials, event date, patient harm and manufacture date to all ips.Corrected revision date.Doi: (b)(6) 2007, dor: (b)(6) 2011 (left hip).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DEPUY ASR XL FEM IMP SIZE 51
• 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: 8901642
• MDR Text Key: 154565710
• Report Number: 1818910-2019-101347
• Device Sequence Number: 0
• Product Code: KXA
• 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: 05/09/2012
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 999890151
• Device Lot Number: 2441726
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/18/2019
• 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