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 09/30/2013

Event Type  Injury  

Event Description

Medwatch report #(b)(4)states: patient underwent an open synovectomy of the left hip joint, as well as removal of the implant from the left hip, with insertion of an antibiotic spacer.This patient had been complaining of a clicking and popping sensation in the left hip.Due to this and the fact that this was a recalled asr implant; it was felt that she should have her implant revised.

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.

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.Corrected information: this product was reported in error.The mfr number, 1818910-2014-10825, is being rejected.

• 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: 3572905
• MDR Text Key: 4034058
• Report Number: 1818910-2014-10825
• 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,Followup
• 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: 32 YR