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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNKNOWN HIP FEMORAL HEAD

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DEPUY INTERNATIONAL LTD - 8010379 UNKNOWN HIP FEMORAL HEAD Back to Search Results
Catalog Number UNK HIP FEMORAL HEAD
Device Problems Nonstandard Device (1420); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Weakness (2145); Test Result (2695); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Investigation summary: no device associated with this report was received for examination. This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive. Depuy considers the investigation closed. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
 
Event Description
Asr claim letter record received. Claim letter alleges muscle weakness and elevated co and cr. Claimant is seeking settlement. Doi: unknown; dor: unrevised; hip unknown.
 
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Brand NameUNKNOWN HIP FEMORAL HEAD
Type of DeviceHIP FEMORAL HEAD
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 Key10488889
MDR Text Key205517064
Report Number1818910-2020-19397
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Remedial Action Recall
Type of Report Initial
Report Date 08/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/03/2020
Is this an Adverse Event Report? Yes
Device Operator
Device Catalogue NumberUNK HIP FEMORAL HEAD
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/19/2020
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 Treatment Data
Date Received: 09/03/2020 Patient Sequence Number: 1
Treatment
UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP FEMORAL AUGMENT; UNKNOWN HIP FEMORAL HEAD; UNKNOWN HIP FEMORAL STEM
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