BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 16741093 · Received April 14, 2023

    Report

    Report Number
    3005180920-2023-00229
    Event Type
    Injury
    Date Received
    April 14, 2023
    Report Date
    April 14, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809163
    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 17 MARCH 2023. LOT 2011664: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-MARCH-2021. EXPIRATION DATE: 2026-02-11. 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. NOTE: THE FIELD "DATE OF THE EVENT" IS EMPTY BECAUSE WE DON'T KNOW WHEN THE USE ERROR WAS DISCOVERED AND WHEN THE PATIENT UNDERWENT TO A REVISION SURGERY.

    Description of Event or Problem · 0

    DURING TOTAL HIP REPLACEMENT SURGERY ON (B)(6) 2021, WRONG SIZE OF THE HEAD, Ø32 INSTEAD OF Ø36 HAS BEEN IMPLANTED (LINER G MUST BE USED WITH HEAD Ø36). THE PATIENT UNDERWENT TO A REVISION SURGERY TO REPLACE THAT COMPONENT. THE REVISION SURGERY DATE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1243731 BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M HIP FEMORAL HEAD LZO MEDACTA INTERNATIONAL SA 01.29.205 2011664 07630030809163

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention