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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL2 STD SIZE 14 CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

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DEPUY FRANCE SAS - 3003895575 CORAIL2 STD SIZE 14 CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM Back to Search Results
Model Number 3L92514
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fatigue (1849); Foreign Body Reaction (1868); Pain (1994); Synovitis (2094); Metal Related Pathology (4530); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 01/07/2019
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Initial reporter occupation: lawyer. Follow-up is being conducted to determine initial reporter contact information. (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
Litigation record received. Patient alleges pain and suffering, serious bodily injuries, and economic loss. Doi: (b)(6) 2010 and (b)(6) 2019, (left hip).
 
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Brand NameCORAIL2 STD SIZE 14
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 FRANCE SAS - 3003895575
7 allee irene joliot-curie
b.p. 256
saint priest cedex 69801
FR 69801
Manufacturer Contact
kate karberg
700 orthopaedic dr.
warsaw, IN 46581-0988
3035526892
MDR Report Key14073630
MDR Text Key288989514
Report Number1818910-2022-06479
Device Sequence Number1
Product Code KWA
UDI-Device Identifier10603295168805
UDI-Public10603295168805
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K070554
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/11/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number3L92514
Device Catalogue Number3L92514
Device Lot Number3163631
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received09/28/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/18/2010
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: 04/11/2022 Patient Sequence Number: 1
Treatment
12/14 ARTICUL 40MM M SPEC+8.5; PINN CAN BONE SCREW 6.5MMX25MM; PINN CAN BONE SCREW 6.5MMX25MM; PINN SECTOR W/GRIPTION 56MM; PINNACLE MTL INS NEUT40IDX56OD
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