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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 45 ASR HIP SYSTEM : HIP METAL FEMORAL HEADS

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DEPUY INTERNATIONAL LTD - 8010379 DEPUY ASR XL FEM IMP SIZE 45 ASR HIP SYSTEM : HIP METAL FEMORAL HEADS Back to Search Results
Catalog Number 999890145
Device Problems Degraded (1153); Noise, Audible (3273)
Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994)
Event Date 11/09/2021
Event Type  Injury  
Event Description
Patient underwent primary total hip re-pavement on (b)(6) 2009 where an asr resurfacing cup with a corail stem was utilized. Patient has presented with a clunking hip in deep flexion and some pain as well as metallosis. On opening the hip, blackened tissue was evident anterior to the cup. There was some soft tissue impingement with metallosis. This black tissue was removed (pseudo tumor) and the asr 300 shell removed. The asr xl head and sleeve were removed from the stem. Corrosion was evident at the head neck junction. The stem was left in situ and a biomet dual mobility shell implanted with a new 28mm metal head. Doi: (b)(6) 2009, dor: (b)(6) 2021, unknown hip.
 
Manufacturer Narrative
(b)(4). 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.
 
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Brand NameDEPUY ASR XL FEM IMP SIZE 45
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. anthony's rd
leeds LS11 8 DT
UK LS11 8 DT
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key12882499
MDR Text Key281325445
Report Number1818910-2021-26366
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K040627
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Remedial Action Recall
Type of Report Initial,Followup
Report Date 11/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number999890145
Device Lot Number2835747
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/08/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/04/2009
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: 11/29/2021 Patient Sequence Number: 1
Treatment
ASR 300 SPIKED CUP SIZE 50; CORAIL2 STD SIZE 9; DEPUY ASR XL FEM IMP SIZE 45; LARGE MOD HEAD ADAPT 12/14 +5
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