MAUDE Adverse Event Report: DEPUY INTL.,LTD 8010379 DEPUY ASR XL FEM IMP SIZE 49; HIP FEMORAL HEAD

Catalog Number 999890149

Device Problems Nonstandard Device (1420); Appropriate Term/Code Not Available (3191)

Patient Problems Host-Tissue Reaction (1297); Pain (1994)

Event Date 05/03/2017

Event Type  Injury  

Manufacturer Narrative

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

Asr revision; asr xl- right; reason(s) for revision: alval/soft tissue reaction.Update: medical records have been reviewed.The information has been captured correctly in the complaint and is available for review for mdr decision.Update 29-jun-2017: medical records indicated elevated metal ion levels.

Manufacturer Narrative

Asr revision.Asr xl- right.Reason(s) for revision: alval/soft tissue reaction.Update: medical records have been reviewed.The information has been captured correctly in the complaint and is available for review for mdr decision.(b)(6) 2017.Medical records indicated elevated metal ion levels.The reported event has been evaluated and will be monitored.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DEPUY ASR XL FEM IMP SIZE 49
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTL.,LTD 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer (Section G): DEPUY INTERNATIONAL LTD.8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 6746548
• MDR Text Key: 81146198
• Report Number: 1818910-2017-21849
• Device Sequence Number: 0
• Product Code: KWY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/29/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 999890149
• Device Lot Number: 2395673
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention