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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ASR ACETABULAR IMPLANT 50; ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS
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DEPUY INTERNATIONAL LTD - 8010379 ASR ACETABULAR IMPLANT 50; ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS Back to Search Results
Catalog Number 999804550
Device Problems Nonstandard Device (1420); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Foreign Body Reaction (1868)
Event Date 09/04/2012
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4).Occupation: lawyer.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Claimsuite alerts received.Asr resurfacing revision.Reason for revision: alval/soft tissue reaction.Doi: (b)(6) 2008 dor: (b)(6) 2012 left hip.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive. depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : previous investigations that have included device history reviews since the asr platform was launched have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.Therefore, if lot codes are provided, no dhr (device history record) review or complaint database search for this individual asr component will be carried out at this time.
 
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Brand Name
ASR ACETABULAR IMPLANT 50
Type of Device
ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD - 8010379
st. anthony's road
leeds LS11 8DT
UK  LS11 8DT
MDR Report Key10969152
MDR Text Key220237252
Report Number1818910-2020-26483
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Remedial Action Recall
Type of Report Initial,Followup
Report Date 11/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number999804550
Device Lot Number2086506
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/20/2020
Initial Date FDA Received12/08/2020
Supplement Dates Manufacturer Received02/18/2021
Supplement Dates FDA Received02/18/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberZ-1749/1816-2011
Patient Sequence Number1
Treatment
ASR ACETABULAR IMPLANT 50; TOTAL ASR FEM IMP SIZE 45; ASR ACETABULAR IMPLANT 50; TOTAL ASR FEM IMP SIZE 45
Patient Outcome(s) Required Intervention;
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