BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE S

    MDR report key: 18525665 · Received January 17, 2024

    Report

    Report Number
    3005180920-2023-01107
    Event Type
    Injury
    Date Received
    January 17, 2024
    Date of Event
    December 21, 2023
    Report Date
    January 17, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809125
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 28 DECEMBER 2023 LOT 2305460: 198 ITEMS MANUFACTURED AND RELEASED ON 15-MARCH-2023. EXPIRATION DATE: 2028-02-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 187 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL INVOLVED IMPLANT BATCH REVIEW PERFORMED ON 28 DECEMBER 2023 ON BALL HEADS: BIPOLAR HEAD 25060.2850 BIPOLAR HEAD Ø28X50 (K091967) LOT. 2245351 LOT 2245351: 101 ITEMS MANUFACTURED AND RELEASED ON 17-APR-2023. EXPIRATION DATE: 2028-03-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 71 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 1 MONTH AND HALF AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE BIPOLAR AND FEMORAL HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1774391 BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE S HIP CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 2305460 07630030809125

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention