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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 TOTAL ASR FEM IMP SIZE 46 ASR HIP SYSTEM : HIP METAL FEMORAL HEADS

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DEPUY INTERNATIONAL LTD - 8010379 TOTAL ASR FEM IMP SIZE 46 ASR HIP SYSTEM : HIP METAL FEMORAL HEADS Back to Search Results
Catalog Number 999803946
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Loss of Range of Motion (2032)
Event Date 02/22/2022
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Initial reporter 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 alert received ad 5 apr 2022. Asr resurfacing revision. Revised due to failed asr with hip pain and painful/restricted rom. Doi: (b)(6) 2007; dor: (b)(6) 2022 left hip.
 
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Brand NameTOTAL ASR FEM IMP SIZE 46
Type of DeviceASR HIP SYSTEM : HIP METAL FEMORAL HEADS
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD - 8010379
st. anthony's road
leeds LS11 8DT
UK LS11 8DT
Manufacturer (Section G)
DEPUY INT'L LTD. 8010379
st anthonys road
leeds LS11 8 DT
UK LS11 8 DT
Manufacturer Contact
kate karberg
700 orthopaedic dr.
warsaw, IN 46581-0988
3035526892
MDR Report Key14167189
MDR Text Key289745750
Report Number1818910-2022-07204
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 04/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number999803946
Device Lot Number2356109
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received05/03/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/29/2007
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-1749/1816-2011

Patient Treatment Data
Date Received: 04/21/2022 Patient Sequence Number: 1
Treatment
ASR ACETABULAR IMPLANT 52; TOTAL ASR FEM IMP SIZE 46
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