MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL REVISION STEM HO 15; CORAIL KAR REVISION IMPLANT : HIP FEMORAL STEM

Model Number	L98015
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Not Applicable (3189); No Code Available (3191)
Date of Event	05/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (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
Deformed corail revision stem and trial after implanting.One of the distal parts is going outside the bone because of a via falsa.
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.¿ removed h6 (patient) 3191 (device revision or replacement).No code available is used to capture surgery prolonged.
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: examination of the returned device and provided x-ray image confirms the reported observation.The root cause is attributed to inadvertent user error.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.Device history lot 5358173.A search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Device history review lot 5358173.A search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.H10 additional narrative: added: e1 (facility name).Corrected: g1 (physical manufacturer).

• Brand Name: CORAIL REVISION STEM HO 15
• 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
• MDR Report Key: 10148485
• Report Number: 1818910-2020-13710
• Device Sequence Number: 19087673
• Product Code: LWJ
• UDI-Device Identifier: 10603295262343
• UDI-Public: 10603295262343
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K093736
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 05/29/2020

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 Expiration Date: 11/30/2024
• Device Model Number: L98015
• Device Catalogue Number: L98115
• Device Lot Number: 5358173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2020
• Initial Date Received by Manufacturer: 05/29/2020
• Supplement Date Received by Manufacturer: 06/25/2020; 06/25/2020; 07/28/2020
• Initial Report FDA Received Date: 06/12/2020
• Supplement Report FDA Received Date: 06/26/2020; 06/29/2020; 07/29/2020
• 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: CORAIL REVISION STEM STD 15; TRIAL CORAIL REVISION STEM 15; CORAIL REVISION STEM STD 15; TRIAL CORAIL REVISION STEM 15
• Outcome Attributed to Adverse Event: Required Intervention