BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR BALL HEAD 12/14 32 SIZE S -3.5

    MDR report key: 10928298 · Received December 1, 2020

    Report

    Report Number
    3005180920-2020-00872
    Event Type
    Injury
    Date Received
    December 1, 2020
    Date of Event
    November 8, 2020
    Report Date
    December 1, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030805158
    PMA / PMN Number
    K072857
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 20 NOVEMBER 2020: LOT 188824: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 7-MAR-2019. EXPIRATION DATE: 2024-02-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. OTHER DEVICE INVOLVED IN THE EVENT: LINER: MPACT 01.32.3241HCT FLAT PE HC LINER ¿32/D LOT. 1902883 (K103721), BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 20 NOVEMBER 2020: LOT 1902883: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 8-MAY-2019. EXPIRATION DATE: 2024-04-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER 4 DAYS AFTER THE PRIMARY SURGERY. THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1396184 COCR BALL HEAD 12/14 32 SIZE S -3.5 BALL HEAD JDI MEDACTA INTERNATIONAL SA 01.25.021 188824 07630030805158

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention