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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 ASR FEM HEAD
Device Problems Noise, Audible (3273); Illegible Information (4050)
Patient Problems Foreign Body Reaction (1868); Pain (1994)
Event Date 01/26/2021
Event Type  Injury  
Manufacturer Narrative
Product complaint #: (b)(4). No 510(k) number provided because this implant is sold internationally with different indications for use; it is currently sold in the us under a different part number. The correction/removal reporting number listed applies to the corresponding product code sold domestically. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
The asr/corail hip was revised due to pain. The surgeon revised the hip, and when he got in he found that then taper on stem has been badly worn out by the asr xl and there was huge metal wear. He femoral component was damaged as seen, but well fixed. Cup also well fixed, severe metallosis in the joint. Both components changed. Postoperative uneventful course. The lot numbers are worn out, and can¿t be read on the implants. Doi: (b)(6) 2009, dor: (b)(6) 2021, 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 Key11567915
MDR Text Key242195180
Report Number1818910-2021-06056
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Other Health Care Professional
Remedial Action Recall
Type of Report Initial,Followup
Report Date 03/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK HIP ASR FEM HEAD
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/13/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/25/2021
Was Device Evaluated by Manufacturer? Yes
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: 03/25/2021 Patient Sequence Number: 1
Treatment
UNK HIP ACETABULAR CUP ASR; UNK HIP FEMORAL HEAD METAL ASR; UNK HIP FEMORAL SLEEVE ASR; UNK HIP FEMORAL STEM CORAIL
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