MAUDE Adverse Event Report: DEPUY INTL., LTD. - 8010379 UNKNOWN DEPUY ASR FEMORAL HEAD; HIP FEMORAL HEAD

Catalog Number UNK-ASR

Device Problem Loss of Osseointegration (2408)

Patient Problem Necrosis (1971)

Event Date 08/08/2014

Event Type  Injury  

Event Description

(b)(6) complaint form received.(b)(4).Patient was revised to address femoral loosening due to avascular necrosis of the femoral bone.

Manufacturer Narrative

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

• Brand Name: UNKNOWN DEPUY ASR FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTL., LTD. - 8010379; st. anthony's rd; leeds LS11 8 D; UK LS11 8 DT
• Manufacturer (Section G): DEPUY INTL., 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: 4052693
• MDR Text Key: 4907219
• Report Number: 1818910-2014-27075
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 08/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: UNK-ASR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 50 YR