BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: MECTACER 01.29.204 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE S

    MDR report key: 17817006 · Received September 26, 2023

    Report

    Report Number
    3005180920-2023-00731
    Event Type
    Injury
    Date Received
    September 26, 2023
    Date of Event
    August 27, 2023
    Report Date
    September 26, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809156
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 31-AUG-2023. LOT 2317261: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-JUL-2023. EXPIRATION DATE: 2028-06-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. OTHER DEVICE INVOLVED: LINER: MPACT 01.32.3241HCAT HOODED PE HC LINER Ø32/D (K132879) LOT 2209989: (B)(4) MANUFACTURED AND RELEASED ON 15-JUN-2022. EXPIRATION DATE: 2027-06-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT 4 DAYS FROM THE PRIMARY, REVISION SURGERY DUE TO DISLOCATION. DURING THE SURGERY, THE SURGEON REALIZED THAT THE ISSUE WAS DUE TO A LARGE OSTEOPHYTE ON THE LATERAL ASPECT OF THE GREAT TROCHANTER. THE SURGEON REMOVED THE OSTEOPHYTE AND INCREASED THE HEAD TO 32L CERAMIC. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649151 BALL HEADS: MECTACER 01.29.204 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE S HIP CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 2317261 07630030809156

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention