MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. UNKNOWN DEPUY ASR FEMORAL HEAD

Catalog Number UNK-ASR

Device Problem Corroded (1131)

Patient Problems Joint Swelling (2356); No Code Available (3191)

Event Date 08/05/2014

Event Type  Injury  

Event Description

Patient contacted depuy as a result of the asr recall to initiate a claim.Medical records were obtained.Upon revision, a bulging capsule, cloudy yellow dark purulent fluid, discolored pseudocapsule, corrosion at the taper/head ball interface, and no bony ingrowth on the acetabular cup were noted.

Manufacturer 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.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.Depuy synthes has been informed that the catalog number and lot number is not available.

• Brand Name: UNKNOWN DEPUY ASR FEMORAL HEAD
• Type of Device: FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD.; st. anthony's rd; leeds LS11 8 D; UK LS11 8 DT
• Manufacturer (Section G): DEPUY INTERNATIONAL LTD.; 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: 4513648
• MDR Text Key: 5410699
• Report Number: 1818910-2015-13463
• 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: Other,Health Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2015
• 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
• Date Manufacturer Received: 01/24/2015
• 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