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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ASR UNI FEMORAL IMPL SIZE 45 ASR HIP SYSTEM : HIP METAL FEMORAL HEADS

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DEPUY INTERNATIONAL LTD - 8010379 ASR UNI FEMORAL IMPL SIZE 45 ASR HIP SYSTEM : HIP METAL FEMORAL HEADS Back to Search Results
Catalog Number 999890245
Device Problem Naturally Worn (2988)
Patient Problems Adhesion(s) (1695); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Necrosis (1971); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 01/11/2011
Event Type  Injury  
Manufacturer Narrative
Product complaint #: (b)(4). Initial reporter occupation: lawyer. Left hip revision reported in 1818910-2021-03502, 1818910-2021-03501, 1818910-2021-03499, 1818910-2021-03500; right hip revision reported in 1818910-2021-03503, 1818910-2021-03489, 1818910-2021-03488. (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Asr supplemental info and medical records were received. After a review of the medical record, the patient was revised to address failed right total hip arthroplasty with likely metal on metal hypersensitivity reaction and cavitary lesion of the right ilium. Operative note reported of scarring of the abductor musculature, alval beneath the head and femoral component, scratches on the femoral head and cavitary defect extended into the ilium there was also some notable necrotic tissue in and around the hip capsule. Doi: (b)(6) 2007, dor: (b)(6) 2011, right hip.
 
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Brand NameASR UNI FEMORAL IMPL 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 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 Key11357885
MDR Text Key232836900
Report Number1818910-2021-03490
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 02/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2012
Device Catalogue Number999890245
Device Lot Number2375981
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 Received03/17/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/03/2007
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: 02/22/2021 Patient Sequence Number: 1
Treatment
ADAPTER SLEEVES 12/14 +2; ASR ACETABULAR CUPS 50; ASR UNI FEMORAL IMPL SIZE 45; SUMMIT POR TAPER SZ5 STD OFF
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