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

Catalog Number UNK-ASR

Device Problem Product Quality Problem (1506)

Patient Problem Failure of Implant (1924)

Event Date 10/29/2013

Event Type  Injury  

Event Description

Medwatch report #(b)(4) states: patient underwent a revision of the right total hip arthroplasty acetabular component as well as removal of hardware of the right acetabular component and femoral head from the femoral component.Post operative diagnosis: mechanical complication of orthopedic device, right hip aseptic loosening right acetabular component other relevant history: this patient was status post bilateral total hip arthroplasties with the depuy asr total implant, who initially did quite well.However, presented in august with elevated metallic iron blood work, and progressive stiffening and pain of the hip joint.

Manufacturer Narrative

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 this 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: FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTL., LTD - 8010379; st. anthony's rd.; leeds, leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): DEPUY INTL., LTD - 8010379; st. anthony's rd.; leeds, leeds LS11 8DT; UK LS11 8DT
• Manufacturer Contact: stacey trick ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714554
• MDR Report Key: 3573277
• MDR Text Key: 4035054
• Report Number: 1818910-2014-10833
• 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: Health Professional
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2014
• 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: 01/08/2014
• 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