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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ASR ACETABULAR CUPS 52 ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS

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DEPUY INTERNATIONAL LTD - 8010379 ASR ACETABULAR CUPS 52 ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS Back to Search Results
Catalog Number 999800752
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Hypersensitivity/Allergic reaction (1907); Pain (1994); Distress (2329); Osteolysis (2377)
Event Date 06/19/2019
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
Litigation and medical records received. Litigation records alleges emotional distress, economic loss as well as punitive damages. After review of medical records patient was revised to addressed failed right total hip arthroplasty due to pain. Mri showed significant pseudotumor and increased metal ion level with cobalt of 64 and chromium of 43. Pseudotumor that was involving her hip abductors coupled with a subsided stem that appeared to be somewhat chronic in nature with marked osteolysis of the femur. The hip was dislocated after clearing all redundant scar tissue. The stem was able to be removed with shoe clip. There was a significant pedestal present. Doi: (b)(6) 2009. Dor: (b)(6) 2019. Right hip.
 
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Brand NameASR ACETABULAR CUPS 52
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 Key12365722
MDR Text Key268072081
Report Number1818910-2021-18620
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
Type of Report Initial,Followup
Report Date 08/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/20/2013
Device Catalogue Number999800752
Device Lot Number2730708
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 Received09/14/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/12/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/25/2021 Patient Sequence Number: 1
Treatment
ASR ACETABULAR CUPS 52; ASR TAP SLV ADAP 12/14 -1; ASR UNI FEMORAL IMPL SIZE 46; CORAIL2 STD SIZE 10
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