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

Model Number	3L92513
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/04/2021
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
Sales rep was informed about a fractured corail hip stem.No surgical delay during revision surgery.Affected side: left.Doi: unknown, dor (planned): (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.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).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.Depuy considers the investigation closed.Should additional info be received, the investigation will be re-opened as necessary.Device history lot : depuy has been unable to retrieve the dhr associated with this device.A nonconformance has been opened in the quality system.Nr- 0175000.Device history review : depuy has been unable to retrieve the dhr associated with this device.A nonconformance has been opened in the quality system.Nr- 0175000.Corrected: h3.

• Brand Name: CORAIL2 STD 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
• Manufacturer (Section G): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 11553189
• Report Number: 1818910-2021-05795
• Device Sequence Number: 4087486
• Product Code: LZO
• UDI-Device Identifier: 10603295168799
• UDI-Public: 10603295168799
• 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: 2005
• Device Explanted Year: 2021
• 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,Followup
• Report Date (Section B): 03/03/2021

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: 3L92513
• Device Catalogue Number: 3L92513
• Device Lot Number: 1958480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 03/03/2021
• Supplement Date Received by Manufacturer: 05/10/2021; 05/13/2021; 03/10/2022
• Initial Report FDA Received Date: 03/23/2021
• Supplement Report FDA Received Date: 05/18/2021; 05/21/2021; 03/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2005
• 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
• Concomitant Medical Products and Therapy/Usage Dates: APEX HOLE ELIM POSITIVE STOP; CORAIL2 STD SIZE 13; DURALOC SECTOR SERIES 56OD; ENDURON 10D 56 OR 68ODX28ID; HIP BA BIO 28MM 12/14 + 8.5; APEX HOLE ELIM POSITIVE STOP; CORAIL2 STD SIZE 13; DURALOC SECTOR SERIES 56OD; ENDURON 10D 56 OR 68ODX28ID; HIP BA BIO 28MM 12/14 + 8.5
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male