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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNK HIP FEMORAL SLEEVE ASR

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DEPUY INTERNATIONAL LTD - 8010379 UNK HIP FEMORAL SLEEVE ASR Back to Search Results
Catalog Number UNK HIP FEMORAL SLEEVE ASR
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 02/24/2020
Event Type  Injury  
Manufacturer Narrative
(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 litigation complaint received ad 18 apr 2022. Litigation alleges pain, suffering and excessive levels of chromium and cobalt. Doi: (b)(6) 2007. Dor: (b)(6) 2020. Affected area: right hip.
 
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Brand NameUNK HIP FEMORAL SLEEVE ASR
Type of DeviceFEMORAL SLEEVE
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
kate karberg
700 orthopaedic dr.
warsaw, IN 46581-0988
3035526892
MDR Report Key14247255
MDR Text Key290394722
Report Number1818910-2022-07834
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 04/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK HIP FEMORAL SLEEVE ASR
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received05/05/2022
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 Treatment Data
Date Received: 04/28/2022 Patient Sequence Number: 1
Treatment
UNK HIP ACETABULAR CUP ASR; UNK HIP FEMORAL HEAD METAL ASR; UNKNOWN HIP FEMORAL STEM
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