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U.S. Department of Health and Human Services

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

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DEPUY INTERNATIONAL LTD - 8010379 UNK HIP FEMORAL HEAD METAL ASR METAL FEMORAL HEAD Back to Search Results
Catalog Number UNK HIP HEAD METAL ASR
Device Problem Noise, Audible (3273)
Patient Problems Fatigue (1849); Pain (1994); Ambulation Difficulties (2544); Physical Asymmetry (4573); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 05/05/2020
Event Type  Injury  
Manufacturer Narrative
(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
Asr revision. Medical records received. After review of medical record patient was revised to addressed pain and elevated metal ions levels. Patient experiencing limping, popping, weakness and left is shorter than his right hip. There was some mascroscopic deposition at the base of the trunnion however there was no mascroscopic damage in the trunnion. Doi: (b)(6) 2009. Dor: (b)(6) 2020; left hip.
 
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Brand NameUNK HIP FEMORAL HEAD METAL ASR
Type of DeviceMETAL 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 Key12197085
MDR Text Key262468533
Report Number1818910-2021-15535
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 06/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK HIP HEAD METAL ASR
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 Received07/30/2021
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: 07/20/2021 Patient Sequence Number: 1
Treatment
+5 TAPER SLEEVE ADAPTER; OFFSET TAPERED STEM WITH DOUFIX S9; S53; S60
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