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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ASR ACETABULAR CUPS 54; ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS

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DEPUY INTERNATIONAL LTD - 8010379 ASR ACETABULAR CUPS 54; ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS Back to Search Results
Catalog Number 999800754
Device Problem Noise, Audible (3273)
Patient Problems Foreign Body Reaction (1868); Necrosis (1971); Loss of Range of Motion (2032); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/07/2020
Event Type  Injury  
Event Description
Left tha completed due to osteoarthritis.A depuy asr head, asr cup, and taper sleeve adapter were used.Patient completed of audible noise and popping in the hip.Revision completed secondary to adverse metal-on-metal reactions and cobalt chromium toxicity.Patient had moderate alval limited to the capsule with small amounts of tissue necrosis around the capsule.Doi: (b)(6) 2007; dor: (b)(6) 2020; left hip.
 
Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
Product complaint # (b)(4).Mfr# 1818910-2022-00387 is being retracted since it was found to be a duplicate of mfr# 1818910-2021-07168.Mfr# 1818910-2021-07168 will be kept for investigation purposes.
 
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Brand Name
ASR ACETABULAR CUPS 54
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
Manufacturer (Section G)
DEPUY INT'L LTD. 8010379
st anthonys road
leeds LS11 8 DT
UK   LS11 8 DT
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key13190901
MDR Text Key283394221
Report Number1818910-2022-00387
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K040627
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Other
Remedial Action Recall
Type of Report Initial,Followup
Report Date 01/06/2022
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 Number999800754
Device Lot Number2316515
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/20/2021
Initial Date FDA Received01/07/2022
Supplement Dates Manufacturer Received02/01/2022
Supplement Dates FDA Received02/15/2022
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 NumberZ-1749/1816-2011
Patient Sequence Number1
Treatment
ADAPTER SLEEVE 11/13 +0; ASR UNI FEMORAL IMPL SIZE 47; S-ROM*SLEEVE PRX ZTT, 18D-LRG; SROM STM STD 36+12L 13X18
Patient Outcome(s) Required Intervention;
Patient Age62 YR
Patient SexMale
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