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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 Naturally Worn (2988)
Patient Problems Foreign Body Reaction (1868); Osteolysis (2377); Unspecified Tissue Injury (4559); Physical Asymmetry (4573); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 09/14/2021
Event Type  Injury  
Manufacturer Narrative
Product complaint #: (b)(4). Initial reporter occupation: lawyer. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Medical record received. After review of medical record patient was revised to address metallosis. Revision notes stated that head was removed with evidenced of corrosion. Soft tissue at the periphery of the acetabular component was removed, after which the curved acetabular osteotomes were used to remove the acetabular component with minimal bone loss. There was a contained defect in the ischium which did not involve the cortex. The greated trochanter had some osteolysis secondary to metal debris but was intact. Limb lengths were improved from the 9 mm short that the patient was before. Doi: (b)(6) 2008, dor: (b)(6) 2020, (right hip).
 
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Brand NameASR ACETABULAR CUPS 54
Type of DeviceASR 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 Key12576501
MDR Text Key274737389
Report Number1818910-2021-21933
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 consumer,other
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 09/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2012
Device Catalogue Number999800754
Device Lot Number2441538
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/26/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/13/2007
Is the Device Single Use? No
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: 10/05/2021 Patient Sequence Number: 1
Treatment
ADAPTER SLEEVES 12/14 +5; ASR ACETABULAR CUPS 54; ASR UNI FEMORAL IMPL SIZE 47; CORAIL2 LAT COXA VARA SIZE 15
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