MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 DEPUY ASR XL FEM IMP SIZE 49; HIP FEMORAL HEAD

Catalog Number 999890149

Device Problems Insufficient Information (3190); Noise, Audible (3273)

Patient Problems Host-Tissue Reaction (1297); Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Tissue Damage (2104); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 05/15/2017

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 took place on (b)(6) 2017, asr xl - left, reason(s) for revision: pain and metalosis.

Manufacturer Narrative

Additional narrative: asr revision to take place on (b)(6) 2017.Asr xl - left.Reason(s) for revision: pain and metallosis.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.

Manufacturer Narrative

Asr xl - left reason(s) for revision: pain and metallosis.Update aug 11, 2017: email notification from kennedys received.There is no new information added that changes the mdr reportability.This complaint was updated on: aug 16 2017.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.

Manufacturer Narrative

Product complaint #
=
> (b)(4).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.

Event Description

Claim letter alleges elevated metal ions, limited mobility, pain with detrimental effects walking ability, inflammation, and crepitus affecting left hip.Added laboratory data, and medical history.Added patient details (patient identifier, sex, and dob).Doi: (b)(6) 2010 - (b)(6) 2017 (left hip).

• Brand Name: DEPUY ASR XL FEM IMP SIZE 49
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 6746973
• MDR Text Key: 81155338
• Report Number: 1818910-2017-21894
• 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: consumer,foreign,other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 2864446
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/30/2017
• Initial Date FDA Received: 07/27/2017
• Supplement Dates Manufacturer Received: 07/27/2017; 08/18/2017; 04/12/2019
• Supplement Dates FDA Received: 08/11/2017; 09/04/2017; 04/30/2019
• 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
• Patient Age: 71 YR