MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL REVISION STEM STD 11; CORAIL KAR REVISION IMPLANT : HIP FEMORAL STEM

Model Number	L98011
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/01/2020
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
It was reported that the surgery was scheduled on (b)(6) 2020 due to the breakage of the stem which was revised at the revision surgery on (b)(6) 2020.The surgeon planned to remove the broken distal end of the stem and perform orif, or to remove all of the stem.No further information is available.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = no device associated with this report was received for examination.Examination of the provided images confirms the reported femoral stem fracture.It is known this patient sustained a major bone fracture while a competitor stem was in-situ and numerous cerclage wires were used in repair when the depuy device was implanted.The depuy stem fracture is in this area.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 = lot 5278921.A device manufacturing records (dhr) review was requested.The dhr analysis showed an initial conformance of this product / lot with regards to its specification.There was no deviation or non-conformance.Device history review = a device manufacturing records (dhr) review was requested.The dhr analysis showed an initial conformance of this product / lot with regards to its specification.There was no deviation or non-conformance.
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 : no device associated with this report was received for examination.Examination of the provided images confirms the reported femoral stem fracture.It is known this patient sustained a major bone fracture while a competitor stem was in-situ and numerous cerclage wires were used in repair when the depuy device was implanted.The depuy stem fracture is in this area.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 : lot 5278921.A device manufacturing records (dhr) review was requested.The dhr analysis showed an initial conformance of this product / lot with regards to its specification.There was no deviation or non-conformance.Device history review : a device manufacturing records (dhr) review was requested.The dhr analysis showed an initial conformance of this product / lot with regards to its specification.There was no deviation or non-conformance.

• Brand Name: CORAIL REVISION STEM STD 11
• 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: 10521467
• Report Number: 1818910-2020-19859
• Device Sequence Number: 3055807
• Product Code: LWJ
• UDI-Device Identifier: 10603295262305
• UDI-Public: 10603295262305
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K093736
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• 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): 08/25/2020

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: L98011
• Device Catalogue Number: L98011
• Device Lot Number: 5278921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2021
• Initial Date Received by Manufacturer: 08/25/2020
• Supplement Date Received by Manufacturer: 12/18/2020; 02/19/2021; 03/24/2021
• Initial Report FDA Received Date: 09/11/2020
• Supplement Report FDA Received Date: 12/18/2020; 03/02/2021; 03/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR