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

Catalog Number 999804249

Device Problems Fracture (1260); Loss of Osseointegration (2408)

Patient Problems Host-Tissue Reaction (1297); Bone Fracture(s) (1870); Necrosis (1971); Pain (1994); Tissue Damage (2104); Osteolysis (2377)

Event Date 04/15/2014

Event Type  Injury  

Event Description

Asr revision.Asr resurfacing system - right.Reason(s) for revision: alval / soft tissue reaction, pain, neck and bone tissue necrosis, osteolysis and possible component loosening - and possible implant fracture.Bi-lateral patient - please see dint (b)(4) for left side revision.

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.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.Additional narrative: 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.Depuy still considers this case closed to capa.

Event Description

Asr revision, asr resurfacing system - right, reason(s) for revision: alval / soft tissue reaction, pain, neck and bone tissue necrosis, osteolysis and possible component loosening - and possible implant fracture.Bi-lateral patient - (b)(4) for left side revision.Update 11 sep 2014 - marked as clinical trial, clinical trial number, new revision date, expiry dates.

• Brand Name: TOTAL ASR FEM IMP SIZE 49
• 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: stacey trick ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714554
• MDR Report Key: 3774855
• MDR Text Key: 21312809
• Report Number: 1818910-2014-17531
• 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: 09/11/2014

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: 11/08/2012
• Device Catalogue Number: 999804249
• Device Lot Number: 2546853
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/11/2014
• Initial Date FDA Received: 04/27/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2008
• 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: 62 YR
• Patient Weight: 109