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: 8460372 · Received March 28, 2019

    Report

    Report Number
    3005180920-2019-00203
    Event Type
    Injury
    Date Received
    March 28, 2019
    Date of Event
    February 27, 2019
    Report Date
    March 28, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809170
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 25 MARCH 2019: LOT 180536: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-JUN-2018. EXPIRATION DATE: 2023-05-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: LINER: MPACT 01.32.3248HCT FLAT PE HC LINER Ø32/F (K103721) LOT 182611: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-JUN-2018. EXPIRATION DATE: 2023-05-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED 4 MONTHS AFTER PRIMARY FOR DISLOCATION OF THE CERAMIC HEAD FROM THE LINER. THE DISLOCATION OCCURED WHILE THE PATIENT WAS SITTING IN A CHAIR AT HOME. THE SURGEON REVISED THE CUP, HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY. AN ANTERIOR APPROACH WAS USED IN THE PRIMARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252443 BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE L HIP CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 180536 07630030809170

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention