MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL2 LAT COXA VARA SIZE 15; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Model Number	3L93715
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	04/01/2020
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
Revision hip (l) - stem revised; (b)(6) hospital, (b)(6) 2020 - patient presented with pain, x-ray taken showing the implant had fractured.Stem, head and liner revised.Jnj representative was present for the case; surgeon commented that patient walked down the stairs and felt a clunk, patient did not fall.
Additional Manufacturer Narrative
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.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.Device history lot: the dhr analysis of the batch returned shows an initial conformance of this product with regards to its specification.For this batch, there was no deviation or non-conformance if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
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.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.Device history lot = the dhr analysis of the batch returned shows an initial conformance of this product with regards to its specification.For this batch, there was no deviation or non-conformance.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CORAIL2 LAT COXA VARA 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 Key: 9963461
• Report Number: 1818910-2020-10803
• Device Sequence Number: 16329105
• Product Code: KWA
• UDI-Device Identifier: 10603295168928
• UDI-Public: 10603295168928
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 04/01/2020

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: 3L93715
• Device Catalogue Number: 3L93715
• Device Lot Number: 5112143
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/01/2020
• Supplement Date Received by Manufacturer: 05/05/2020; 05/05/2020
• Initial Report FDA Received Date: 04/15/2020
• Supplement Report FDA Received Date: 05/05/2020; 05/05/2020
• 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: DELTA CER INSERT 36ID X 58OD; DLT TS CER HD 12/14 36MM +5.0; DELTA CER INSERT 36ID X 58OD; DLT TS CER HD 12/14 36MM +5.0
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR