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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 DEPUY ASR XL FEM IMP SIZE 53 HIP FEMORAL HEAD

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DEPUY INTERNATIONAL LTD. 8010379 DEPUY ASR XL FEM IMP SIZE 53 HIP FEMORAL HEAD Back to Search Results
Catalog Number 999890153
Device Problems Nonstandard Device (1420); Insufficient Information (3190)
Patient Problem Host-Tissue Reaction (1297)
Event Date 12/14/2016
Event Type  Injury  
Manufacturer Narrative
No 510(k) number provided because this implant is sold internationally with different indications for use; it is currently sold in the us under a different part number. The correction/removal reporting number listed applies to the corresponding product code sold domestically. 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 the investigation closed at this time. Should the product and/or additional information be received, the investigation will be re-opened.
 
Event Description
Patient underwent a revision to address alval/soft tissue reaction.
 
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Brand NameDEPUY ASR XL FEM IMP SIZE 53
Type of DeviceHIP FEMORAL HEAD
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD. 8010379
st. anthony's rd
leeds, leeds LS11 8 DT
UK LS11 8 DT
Manufacturer (Section G)
DEPUY INTERNATIONAL LTD. 8010379
st. anthony's rd
leeds, leeds LS11 8 DT
UK LS11 8 DT
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw, IN 46581
5743725905
MDR Report Key6245349
MDR Text Key64611942
Report Number1818910-2017-10731
Device Sequence Number0
Product Code KWY
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Remedial Action Recall
Type of Report Initial
Report Date 12/20/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2017
Is this an Adverse Event Report? Yes
Device Operator
Device Catalogue Number999890153
Device Lot Number1941353
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/20/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/11/2005
Is the Device Single Use? Yes
Type of Device Usage Initial
Removal/Correction NumberZ-1749/1816-2011

Patient Treatment Data
Date Received: 01/12/2017 Patient Sequence Number: 1
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