MAUDE Adverse Event Report: DEPUY INTL., LTD - 8010379 UNKNOWN DEPUY ASR FEMORAL HEAD SIZE 53

Catalog Number UNK-ASR

Device Problem Product Quality Problem (1506)

Patient Problem Unspecified Infection (1930)

Event Date 02/25/2013

Event Type  Injury  

Event Description

(b)(4) states: patient failed left hip implant with metallic synovitis, left hip joint, due to recalled asr implant.A revision of the left total hip replacement was performed.As well as a full synovectomy of the left hip joint for synovitis.Other relevant history: this patient is a (b)(6) male who had a bilateral hip replacement performed back on (b)(6) 2009.Both hips used a 60mm diameter asr shell with 53 head on both sides.The right hip was causing problems and was revised (b)(6) 2010.The right hip has recovered well.Now the left hip has started causing pain.

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.Ref wwcapa (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 SIZE 53
• 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: 3572809
• MDR Text Key: 4139798
• Report Number: 1818910-2014-10816
• 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: 01/13/2014
• 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
• Patient Age: 57 YR