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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL2 STD SIZE 12 CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

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DEPUY FRANCE SAS - 3003895575 CORAIL2 STD SIZE 12 CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM Back to Search Results
Model Number 3L92512
Device Problem Loss of Osseointegration
Event Date 11/11/2019
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

Pinnacle litigation record received. Litigation alleges discomfort, pain, weakness, walking difficulty, osteolysis, metallosis, elevated metal ions, pseudotumor, loosening of cup and stem, leg length discrepancy( 1/2 inch shorter than the right leg), bone loss, limited mobility, muscle and ligament injury. The plaintiff is seeking compensatory damages. Doi: (b)(6) 2010; dor: (b)(6) 2019; left hip.

 
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Brand NameCORAIL2 STD SIZE 12
Type of DeviceCORAIL AMT CEMENTLESS 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 INT'L LTD. 8010379
st anthonys road
leeds LS11 8 DT
UK  LS11 8 DT
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw , IN 46581-0988
6107428552
MDR Report Key9818031
Report Number1818910-2020-07444
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/19/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/11/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number3L92512
Device Catalogue Number3L92512
Device LOT Number5019217
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 Received04/13/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/11/2009
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: 03/11/2020 Patient Sequence Number: 1
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