BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 STD SIZE 8

    MDR report key: 17859724 · Received October 3, 2023

    Report

    Report Number
    1818910-2023-19858
    Event Type
    Injury
    Date Received
    October 3, 2023
    Date of Event
    September 20, 2023
    Report Date
    October 3, 2023
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    LZO
    UDI-DI
    10603295168737
    PMA / PMN Number
    K192946
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, 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 REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY = ACCORDING TO THE INFORMATION RECEIVED, ¿PERIPROSTHETIC FRACTURE FOLLOWING A FALL". THE PRODUCT WAS NOT RETURNED TO DEPUY SYNTHES, HOWEVER A RADIOGRAPH WAS PROVIDED FOR REVIEW. REVIEW OF THE RADIOGRAPH EVIDENCE FOUND NOTHING INDICATIVE OF A DEVICE NONCONFORMANCE WITH THE CORAIL2 STD SIZE 8 NOR DEFECTS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [3L92507/ 1834614] NUMBER, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED DURING MANUFACTURING. THE OVERALL COMPLAINT WAS UNCONFIRMED AS THE OBSERVED CONDITION OF THE CORAIL2 STD SIZE 8 WOULD NOT CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT = A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [3L92507/ 1834614] NUMBER, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED DURING MANUFACTURING. DEVICE HISTORY REVIEW = A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [3L92507/ 1834614] NUMBER, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED DURING MANUFACTURING.

    Description of Event or Problem · 0

    PATIENT WAS REVISED FOR A PERIPROSTHETIC FRACTURE AND PAIN, FOLLOWING A FALL. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: LEFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589968 CORAIL2 STD SIZE 8 CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM LZO DEPUY IRELAND - 9616671 1834614 10603295168737

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention ARTICULEZE M HEAD 36MM +5| PINNACLE MTL INS NEUT36IDX50OD