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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 KAR HA FEMORAL STEM 14MM CORAIL KAR REVISION IMPLANT : HIP FEMORAL STEM

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DEPUY FRANCE SAS - 3003895575 KAR HA FEMORAL STEM 14MM CORAIL KAR REVISION IMPLANT : HIP FEMORAL STEM Back to Search Results
Catalog Number L92524
Device Problem Loss of Osseointegration
Event Date 06/17/2020
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

Patient presented with hip pain. X-rays showed that the stem appeared loose. The depuy stem, head and insert were removed. Surgeon noted that there was no sign of infection, however swabs were taken. A new depuy synthes marathon cup was reimplanted into the pinnacle acetabular cup. For the femoral side, the surgeon chose to implant a medacta stem and head.

 
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Brand NameKAR HA FEMORAL STEM 14MM
Type of DeviceCORAIL KAR REVISION IMPLANT : HIP FEMORAL STEM
Manufacturer (Section D)
DEPUY FRANCE SAS - 3003895575
7 allee irene joliot-curie
b.p. 256
saint priest cedex 69801
FR  69801
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw , IN 46581-0988
6107428552
MDR Report Key10213099
Report Number1818910-2020-14696
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 06/18/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/30/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberL92524
Device LOT Number2276148
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/22/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/02/2007
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 06/30/2020 Patient Sequence Number: 1
Treatment
ARTICULEZE M HEAD 36MM +1.5
PINN MAR +4 10D 36IDX60OD
UNKNOWN HIP ACETABULAR CUP
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