BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: COCR BALL HEAD 12/14 Ø 32 SIZE S -3.5

    MDR report key: 9334638 · Received November 18, 2019

    Report

    Report Number
    3005180920-2019-00972
    Event Type
    Injury
    Date Received
    November 18, 2019
    Date of Event
    October 24, 2019
    Report Date
    November 18, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030805158
    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 4 NOVEMBER 2019: LOT 187058: 170 ITEMS MANUFACTURED AND RELEASED ON 8-DEC-2018. EXPIRATION DATE: 2023-11-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 147 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. BATCH REVIEWS PERFORMED ON 30 OCTOBER 2019: STEM: QUADRA-C 01.12.054 CEMENTED, MIRROR POLISHING LAT STEM SIZE 4 12/14 (K083558) LOT 171586: 30 ITEMS MANUFACTURED AND RELEASED ON 20-GUN-2017. EXPIRATION DATE: 2022-05-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 18 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. THE LOOSE HIP SHELL IS NOT MARKETED IN THE USA.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED 2,5 MONTHS AFTER THE PRIMARY DUE TO LOOSE STEM AND CUP. ALL IMPLANTS WERE REVISED. THE PATIENT WAS IN ISOLATION BECAUSE OF MRSA INFECTION AND HE ALSO HAS A LONG HISTORY OF DISEASES. IT IS UNKNOWN WHAT WAS THE PRIMARY REASON OF THE REVISION SURGERY (INFECTION, PAIN OR IMPLANTS LOOSENING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1133021 BALL HEADS: COCR BALL HEAD 12/14 Ø 32 SIZE S -3.5 HIP FEMORAL COCR HEAD JDI MEDACTA INTERNATIONAL SA 187058 07630030805158

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention