MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL2 STD SIZE 13; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Catalog Number	3L92513
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	10/23/2019
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 primary surgery was performed via tha with a cup (manufactured by stryker), the stem (p:n/ 3l92513) and the head (p:n/ 136536320) on (b)(6) 2018.It was reported that the patient fell from the second floor on (b)(6) 2019.The fracture around the stem and tibial plateau fracture occurred.The revision surgery was performed by replacing the stem and the head with an arcos (manufactured by zimmer biomet, p:n/ unknown) and a plate (manufactured by synthes, p:n/ unknown) on (b)(6) 2019.The surgical delay and the patient outcome are unknown.No further information is available.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.Product complaint # (b)(4).Investigation summary : no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CORAIL2 STD SIZE 13
• 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: 9322138
• Report Number: 1818910-2019-116174
• Device Sequence Number: 18937320
• Product Code: KWA
• UDI-Device Identifier: 10603295168799
• UDI-Public: 10603295168799
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K042992
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2019

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 Catalogue Number: 3L92513
• Device Lot Number: 5269206
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/20/2019
• Supplement Date Received by Manufacturer: 01/13/2020
• Initial Report FDA Received Date: 11/14/2019
• Supplement Report FDA Received Date: 01/14/2020
• 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: COMPETITOR CUP; DELTA CER HEAD 12/14 36MM +5
• Outcome Attributed to Adverse Event: Required Intervention