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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL AMT COLLAR SIZE 15; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM
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DEPUY FRANCE SAS - 3003895575 CORAIL AMT COLLAR SIZE 15; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM Back to Search Results
Model Number 3L92505
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Bone Fracture(s) (1870); No Code Available (3191)
Date of Event 07/07/2020
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 patient femur fractured and dislocated so the doctor replaces head and stem with new revision stem and head.Doi: (b)(6) 2020, dor: (b)(6) 2020, right side.
 
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 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.H10 additional narrative:.
 
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Brand Name
CORAIL AMT COLLAR SIZE 15
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 Key10295861
Report Number1818910-2020-16229
Device Sequence Number3065205
Product Code KWA
UDI-Device Identifier10603295168713
UDI-Public10603295168713
Combination Product (Y/N)N
Initial Reporter StateIN
Initial Reporter CountryUS
PMA/510(K) Number
K042992
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 07/07/2020
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 Number3L92505
Device Catalogue Number3L92505
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 07/07/2020
Supplement Date Received by Manufacturer08/19/2020
Initial Report FDA Received Date07/20/2020
Supplement Report FDA Received Date08/20/2020
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
DELTA CER HEAD 12/14 36MM +12; UNKNOWN HIP ACETABULAR LINERS; DELTA CER HEAD 12/14 36MM +12; UNKNOWN HIP ACETABULAR LINERS
Outcome Attributed to Adverse Event Required Intervention;
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