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

Model Number	3L93713
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/04/2021
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 of a corail stem right side because of fracture at neck area.A cementless hip tep was implanted on (b)(6) 2019.At early may, the patient underwent a revision with head and inlay change because of an early infection.While lifting an object weighing 15 kg, the patient experienced acute pain in the hip and inability to bear weight.The diagnostics performed showed a complete fracture of the prosthesis in the neck region.After preparation, surgical revision via transfemoral approach with prosthesis replacement was performed.Doi: (b)(6) -2019.Dor: (b)(6) 2021.
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.H10 additional narrative:  added: b5, d10.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: d3, g1.
Event or Problem Description
Additional information indicated that the fracture of the stem was the reason for revision.Affected side was right hip.
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 images confirmed the reported event.This device was manufactured on 13-dec-2018.Depuy considers the investigation closed.Should additional info be received, the investigation will be re-opened as necessary.Device history lot : 1) quantity manufactured: (b)(4).2) date of manufacture: 13-dec-2018, 3) any anomalies or deviations identified in dhr: none, 4) expiry date: 30-nov-2023, 5) ifu reference: 78409455.

• Brand Name: CORAIL2 LAT COXA VARA 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: 11696186
• Report Number: 1818910-2021-08319
• Device Sequence Number: 3014838
• Product Code: LZO
• UDI-Device Identifier: 10603295168904
• UDI-Public: 10603295168904
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K190344
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• 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): 04/04/2021

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: 3L93713
• Device Catalogue Number: 3L93713
• Device Lot Number: 5332252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2021
• Initial Date Received by Manufacturer: 04/04/2021
• Supplement Date Received by Manufacturer: 05/05/2021; 06/11/2021; 07/27/2021
• Initial Report FDA Received Date: 04/20/2021
• Supplement Report FDA Received Date: 05/17/2021; 06/24/2021; 07/28/2021
• 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: ALTRX NEUT 36IDX58OD; CORAIL2 LAT COXA VARA SIZE 13; DLT TS CER HD 12/14 36MM +8.5; PINNACLE 100 ACET CUP 58MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Weight: 92