BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 32 SIZE S

    MDR report key: 11831969 · Received May 17, 2021

    Report

    Report Number
    3005180920-2021-00391
    Event Type
    Injury
    Date Received
    May 17, 2021
    Date of Event
    April 19, 2021
    Report Date
    May 17, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809156
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 27 APRIL 2021: LOT 1902992: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-JUL-2019. EXPIRATION DATE: 2024-06-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 176 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL DEVICES INVOLVED. BATCH REVIEW PERFORMED ON 27 APRIL 2021: LINER: MPACT 01.32.3239HCAT HOODED PE HC LINER Ø32/C (K132879) LOT 1906073: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-AUG-2019. EXPIRATION DATE: 2024-07-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER 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. THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE DISLOCATION HAPPENED AT THE HOSPITAL ON THE SAME DAY OF PRIMARY SURGERY IN POST-OP RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733080 MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 32 SIZE S HIP CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 01.29.204 1902992 07630030809156

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention