MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL REVISION STEM HO 10; CORAIL KAR REVISION IMPLANT : HIP FEMORAL STEM

Model Number	L98110
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Hcp is reporting a distal fracture of corail stem.Doi: (b)(6) 2022; dor: (b)(6) 2022; unknown hip.
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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : the device associated with this report was received for analysis.Based in the visual examination of the part, it was confirmed that stem was fractured at the distal portion of the device's plug.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot : bfarm dhr review request: product description: corail revision stem ho 10, product code: 5262301, lot number: l98110.Please provide: 1) quantity manufactured: (b)(4), 2) date of manufacture: 03/16/2016, 3) any anomalies or deviations identified in dhr: none.No deviation or non-conformance was identified.4) expiry date: 02/28/2021, 5) ifu reference: w90956 rev.C.Device history review : a manufacturing record evaluation was performed for the finished device (5262301/l98110) product and lot numbers, and no non-conformances were identified.

• Brand Name: CORAIL REVISION STEM HO 10
• Common Device Name: CORAIL KAR REVISION 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
• Manufacturer (Section G): DEPUY FRANCE SAS 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15428983
• Report Number: 1818910-2022-17978
• Device Sequence Number: 4679534
• Product Code: LZO
• UDI-Device Identifier: 10603295262381
• UDI-Public: 10603295262381
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K093736
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/15/2022

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 Expiration Date: 02/28/2021
• Device Model Number: L98110
• Device Catalogue Number: L98110
• Device Lot Number: 5262301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2022
• Supplement Date Received by Manufacturer: 10/10/2022; 11/29/2022
• Initial Report FDA Received Date: 09/15/2022
• Supplement Report FDA Received Date: 10/14/2022; 11/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown