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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL DEPUY ASR XL FEM IMP SIZE 45 HIP IMPLANT

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DEPUY INTERNATIONAL DEPUY ASR XL FEM IMP SIZE 45 HIP IMPLANT Back to Search Results
Catalog Number 999890145
Event Date 01/28/2011
Event Type  Injury  
Manufacturer Narrative

Depuy considers this investigation closed. Should the product or additional information that changes this conclusion be received, the investigation will be reopened.

 
Event Description

Asr revision. Asr hip xl (left). Reason(s) for revision: pain. Update: corrected system used to xl, implant date and added products.

 
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 the investigation closed at this time. Should the product and/or additional information be received, the investigation will be re-opened. The correction/removal reporting number listed applies to the corresponding product code sold domestically.

 
Event Description

Revised for pain and loose fem stem.

 
Search Alerts/Recalls

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Brand NameDEPUY ASR XL FEM IMP SIZE 45
Type of DeviceHIP IMPLANT
Manufacturer (Section D)
DEPUY INTERNATIONAL
st. anthonys rd
leeds
UNITED KINGDOM
Manufacturer (Section G)
DEPUY INTERNATIONAL
st. anthonys rd
leeds
UNITED KINGDOM
Manufacturer Contact
katherine seppa
700 orthopaedic drive
warsaw , IN 46582
MDR Report Key2550262
Report Number1818910-2012-11202
Device Sequence Number1
Product CodeKWA
Report Source Manufacturer
Source Type Other,Foreign
Reporter Occupation Patient
Remedial Action Recall
Type of Report Initial,Followup
Report Date 04/25/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/26/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number999890145
Device LOT Number2017504
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received06/27/2011
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 NumberZ1749/1816-2011

Patient TREATMENT DATA
Date Received: 04/26/2012 Patient Sequence Number: 1
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