BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: COCR BALL HEAD 12/14 Ø 36 SIZE L +3.5

    MDR report key: 9278374 · Received November 5, 2019

    Report

    Report Number
    3005180920-2019-00942
    Event Type
    Injury
    Date Received
    November 5, 2019
    Date of Event
    October 10, 2019
    Report Date
    November 5, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030805226
    PMA / PMN Number
    K080885
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 22 OCTOBER 2019: LOT: 1900782: 45 ITEMS MANUFACTURED AND RELEASED ON 05-JUN-2019. EXPIRATION DATE: 2024-05-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 16 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ANOTHER DEVICE INVOLVED IN THE CASE: LINER: MPACT 01.32.3652HCT FLAT PE HC LINER 36/G LOT. 1810222 (K103721). BATCH REVIEW PERFORMED ON 22 OCTOBER 2019: LOT: 1810222: 40 ITEMS MANUFACTURED AND RELEASED ON 10-DEC-2018. EXPIRATION DATE: 2023-11-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 21 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED 1 DAY AFTER THE PRIMARY DUE TO DISLOCATION (HEAD FROM THE LINER). THE SURGEON REVISED THE STEM MASTERLOC LATERALIZED #10 WITH A MASTERLOC LATERALIZED #12, THE 36MM COCR HEAD L WITH A 40MM BIOLOX DELTA HEAD L, AND THE MPACT FLAT LINER HC 36/G WITH A MPACT FLAT LINER HC 40/G. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON USES ORTHOVIEW TEMPLATING. THE FEMORAL HEAD AND NECK WERE ANTERIORLY ROTATED AND THE PATIENT THE DISLOCATED ANTERIORLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1072012 BALL HEADS: COCR BALL HEAD 12/14 Ø 36 SIZE L +3.5 COCR BALL HEAD JDI MEDACTA INTERNATIONAL SA 1900782 07630030805226

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention