MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 TOTAL ASR FEM IMP SIZE 47; HIP FEMORAL HEAD

Catalog Number 999804047

Device Problem Insufficient Information (3190)

Patient Problems Host-Tissue Reaction (1297); Necrosis (1971); Pain (1994); No Code Available (3191)

Event Date 04/26/2014

Event Type  Injury  

Event Description

Asr revision asr resurfacing system - left reason(s) for revision: alval, fluid, soft tissue thickening, raised metal ion levels, dark brown / black fluid, staining of joint and necrotic tissue.Update - added additional reason for revision, amended revision date, amended lot number for head, attached surgeon form, added file handler details.Taken from claim suite dated (b)(6) and scf dated (b)(6) 2014 reason for revision : pain.

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.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 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.(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.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Depuy still considers this case closed to capa.

Event Description

Asr revision.Asr resurfacing system - left.Reason(s) for revision: alval, fluid, soft tissue thickening, raised metal ion levels, dark brown / black fluid, staining of joint and necrotic tissue.Update - added additional reason for revision, amended revision date, amended lot number for head, attached surgeon form, added file handler details.Taken from claimsuite dated 8th aug and scf dated 7th august 2014.Reason for revision : pain.Update - marked as legal , added kid and filled out expiry dates.Taken from kennedys alert dated 5th dec 2014.(b)(4).

• Brand Name: TOTAL ASR FEM IMP SIZE 47
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS11 8 D; UK LS11 8 DT
• Manufacturer (Section G): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS11 8 D; UK LS11 8 DT
• Manufacturer Contact: steve dowell ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714918
• MDR Report Key: 4007241
• MDR Text Key: 4773481
• Report Number: 1818910-2014-25611
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Patient
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/08/2014

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: 01/27/2009
• Device Catalogue Number: 999804047
• Device Lot Number: 1156636
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/08/2014
• Initial Date FDA Received: 08/13/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2004
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR