BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: COCR BALL HEAD 12/14 36 SIZE M 0

    MDR report key: 10705416 · Received October 20, 2020

    Report

    Report Number
    3005180920-2020-00718
    Event Type
    Injury
    Date Received
    October 20, 2020
    Date of Event
    September 19, 2020
    Report Date
    October 20, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030805219
    PMA / PMN Number
    K080885
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED BY MEDACTA REGUALTORY AFFAIRS DEPARTMENT ON 2 OCTOBER 2020 LOT 186285: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 7-NOV-2018. EXPIRATION DATE: 2023-10-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 46 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. OTHER DEVICES INVOLVED IN THE EVENT: LINER: MPACT 01.32.3652HCT FLAT PE HC LINER Ø36/G LOT. 2000184 (K103721). BATCH REVIEW PERFORMED BY MEDACTA REGUALTORY AFFAIRS DEPARTMENT ON 2 OCTOBER 2020 LOT 2000184:(B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-MAR-2020. EXPIRATION DATE: 2025-02-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 11 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    AFTER THE PRIMARY HIP SURGERY, WHEN THE PATIENT WAS BEING TRANSFERRED TO ANOTHER BED, THE PATIENT'S HIP DISLOCATED (THE HEAD DISLOCATED FROM THE LINER). ONE DAY AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE MASTERLOC CEMENTLESS MECTAGRIP STEM STD #7 WITH A MASTERLOC CEMENTLESS MECTAGRIP STEM LAT PLUS #7 AND THE 36MM COCR HEAD M WITH A 36MM COCR HEAD XL. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1167623 BALL HEADS: COCR BALL HEAD 12/14 36 SIZE M 0 COCR BALL HEAD JDI MEDACTA INTERNATIONAL SA 01.25.031 186285 07630030805219

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention