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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL CEM STEM STD S12 HIP FEMORAL STEM

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DEPUY FRANCE SAS - 3003895575 CORAIL CEM STEM STD S12 HIP FEMORAL STEM Back to Search Results
Catalog Number L96412
Device Problems Loss of or Failure to Bond (1068); Loss of Osseointegration (2408)
Patient Problems Pain (1994); Inadequate Osseointegration (2646); No Code Available (3191)
Event Date 11/01/2019
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 received hip-tep left side in another hospital on (b)(6) 2011. Revision on (b)(6) 2019 because of pain and pe wear. Intraoperatively a loosening of the cemented stem was seen, so this was revised as well.

 
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Brand NameCORAIL CEM STEM STD S12
Type of DeviceHIP FEMORAL STEM
Manufacturer (Section D)
DEPUY FRANCE SAS - 3003895575
7 allee irene joliot-curie
b.p. 256
saint priest cedex IN 69801
FR 69801
Manufacturer (Section G)
DEPUY INTERNATIONAL LTD. 8010379
st. anthony's rd
leeds IN LS11 8 DT
UK LS11 8 DT
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, PA 19380-0988
6103142063
MDR Report Key9554532
MDR Text Key185373674
Report Number1818910-2020-00643
Device Sequence Number1
Product Code KXA
Combination Product (Y/N)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 01/15/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/06/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberL96412
Device LOT Number3328128
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/15/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/11/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/08/2011
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 01/06/2020 Patient Sequence Number: 1
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