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

Model Number	3L92514
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	04/25/2020
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
The patient underwent preliminary surgery in 2009, and in 2014 underwent a revision surgery in the asr acetabular portion as a result of metallic infection, with the original stem remaining in the face.At the beginning of the week, the patient sat down in his vehicle and made a rotating motion with his leg, feeling sharp pain and from that moment he could no longer move his leg, evacuated with an ambulance to the hospital and xray photography revealed that the stem had broken in his neck.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report. .
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : examination of the returned femoral stem confirms the reported material fracture.The stem was evaluated by a depuy material scientist.The root cause was attributed to fatigue.No material or manufacturing defects were observed in the titanium femoral stem that could have contributed to fracture 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.Follow-up 2 is being submitted in order to correct the g4 (date received by manufacturer) of follow-up 1.The correct g4 date is 2-jun-2020.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: CORAIL2 STD SIZE 14
• 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 Key: 10028717
• Report Number: 1818910-2020-11725
• Device Sequence Number: 3752321
• Product Code: KWA
• UDI-Device Identifier: 10603295168805
• UDI-Public: 10603295168805
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K042992
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/25/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3L92514
• Device Catalogue Number: 3L92514
• Device Lot Number: MU1102146/038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2020
• Initial Date Received by Manufacturer: 04/25/2020
• Supplement Date Received by Manufacturer: 06/02/2020; 06/02/2020; 06/22/2020
• Initial Report FDA Received Date: 05/06/2020
• Supplement Report FDA Received Date: 06/03/2020; 06/03/2020; 06/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN HIP FEMORAL HEAD; UNKNOWN HIP FEMORAL HEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR