BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR BALL HEAD 12/14 Ø 28 SIZE M 0

    MDR report key: 8054894 · Received November 9, 2018

    Report

    Report Number
    3005180920-2018-00881
    Event Type
    Injury
    Date Received
    November 9, 2018
    Date of Event
    October 12, 2018
    Report Date
    November 9, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030805110
    PMA / PMN Number
    K072857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 09 NOVEMBER 2018. LOT 180322: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22 MAY 2018. EXPIRATION DATE: 2023-05-10 NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. OTHER DEVICE INVOLVED: LINER CC E CC LIGHT FLAT PE HC LINER Ø 28 / C REFERENCE 01.26.2839HCT (LZO). LOT 177500: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13 MARCH 2018 . EXPIRATION DATE: 2023-02-27 NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR ON NOVEMBER 09, 2018. REVISION OCCURRED 1 MONTH AFTER TOTAL HIP ARTHROPLASTY DUE TO LUXATION IN A (B)(6) WOMAN. THIS EVENT MAY BE DUE TO A TRAUMATIC EVENT BUT NO INFORMATION THAT CAN CONFIRM THIS HYPOTHESIS WAS REPORTED. THE CAUSE OF THIS FAILURE CANNOT BE DETERMINED, BUT THERE IS NO REASON TO SUSPECT A FAULTY IMPLANT.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED, 1 MONTH AFTER PRIMARY SURGERY, DUE TO HIP LUXATION. LUXATION FROM THE HEAD TO THE LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894753 COCR BALL HEAD 12/14 Ø 28 SIZE M 0 COCR BALL HEAD JDI MEDACTA INTERNATIONAL SA 180322 07630030805110

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention