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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL2 LAT COXA VARA SIZE 18; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM
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DEPUY FRANCE SAS - 3003895575 CORAIL2 LAT COXA VARA SIZE 18; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM Back to Search Results
Model Number 3L93718
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event 12/28/2020
Type of Reportable Event Serious Injury
Additional 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 or Problem Description
It was reported that the implants were removed due to infection.Doi: (b)(6) 2020 (cup and stem), (b)(6) 2020 (liner and head), dor: (b)(6) 2020, affected side: left hip.
 
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.
 
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Brand Name
CORAIL2 LAT COXA VARA SIZE 18
Common Device Name
CORAIL 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
MDR Report Key11154019
Report Number1818910-2021-00864
Device Sequence Number10954280
Product Code KWL
UDI-Device Identifier10603295168942
UDI-Public10603295168942
Combination Product (Y/N)N
Initial Reporter StateGA
Initial Reporter CountryUS
PMA/510(K) Number
K123991
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 12/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Model Number3L93718
Device Catalogue Number3L93718
Device Lot Number5332405
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 12/28/2020
Supplement Date Received by Manufacturer02/08/2021
Initial Report FDA Received Date01/12/2021
Supplement Report FDA Received Date02/09/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
ALTRX +4 NEUT 36IDX56OD; ARTICULEZE M HEAD 36MM +8.5; PINN SECTOR W/GRIPTION 56MM; ALTRX +4 NEUT 36IDX56OD; ARTICULEZE M HEAD 36MM +8.5; PINN SECTOR W/GRIPTION 56MM
Outcome Attributed to Adverse Event Required Intervention;
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