MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 DEPUY ASR XL FEM IMP SIZE 43; HIP FEMORAL HEAD

Catalog Number 999890143

Device Problem Malposition of Device (2616)

Patient Problems Host-Tissue Reaction (1297); Foreign Body Reaction (1868); Pain (1994); No Information (3190)

Event Date 04/23/2015

Event Type  Injury  

Manufacturer Narrative

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.The asr platform was voluntarily recalled from the market in (b)(6) 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 (b)(4).Depuy considers the investigation closed at this time.Should the product and/or additional information be received, the investigation will be re-opened.(b)(4).

Event Description

Asr revision.Asr xl- left.Reason(s) for revision: component malalignment.

Manufacturer Narrative

Depuy still considers this investigation closed.

Event Description

(b)(6) 2015 - update - rcvd scf and updated claimsuite - reason for revision is pain not malalignment - (b)(6) 2015 - email rcvd to conf that additional info states metallosis.(b)(6).

Manufacturer Narrative

Asr revision.Asr xl- left.Reason(s) for revision: component malalignment (b)(4) 2015 - update - rcvd scf and updated claimsuite - reason for revision is pain not malalignment - kf (b)(4) 2015.(b)(4) 2015 - email rcvd to conf that additional info states metalosis +++ - kf (b)(4) 2015.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

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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 43
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• MDR Report Key: 4999327
• MDR Text Key: 22829182
• Report Number: 1818910-2015-27527
• 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,other
• Remedial Action: Recall
• Type of Report: Followup,Followup,Followup
• Report Date: 08/13/2015

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: Physician
• Device Expiration Date: 06/15/2010
• Device Catalogue Number: 999890143
• Device Lot Number: 1917768
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/13/2015
• Supplement Dates Manufacturer Received: 12/14/2017; 07/03/2018; 08/02/2018
• Supplement Dates FDA Received: 01/05/2018; 07/27/2018; 08/21/2018
• 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