BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE L

    MDR report key: 19749510 · Received July 16, 2024

    Report

    Report Number
    3005180920-2024-00550
    Event Type
    Injury
    Date Received
    July 16, 2024
    Date of Event
    June 20, 2024
    Report Date
    July 16, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809170
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 03 JULY 2024 LOT 2115379: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-FEB-2022. EXPIRATION DATE: 2027-02-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL REVISED IMPLANT BATCH REVIEW PERFORMED ON 03 JULY 2024 ON LINER: IMPACT 01.32.3244 HCT FLAT PE HC LINER Ø32/E (K103721) LOT. 2201695 LOT 2201695: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-FEB-2022. EXPIRATION DATE: 2027-02-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) 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 YEAR 9 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER. THE SURGEON REVISED THE CUP, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694192 BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE L HIP CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 2115379 07630030809170

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention