BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE S

    MDR report key: 8486478 · Received April 5, 2019

    Report

    Report Number
    3005180920-2019-00244
    Event Type
    Injury
    Date Received
    April 5, 2019
    Date of Event
    March 8, 2019
    Report Date
    April 5, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809194
    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 01 APRIL 2019: LOT 184381: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-OCT-2018. EXPIRATION DATE: 2023-09-19. 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 DEVICE INVOLVED: MPACT 01.32.3648HCT FLAT PE HC LINER Ø36/F (K103721) LOT. 184754: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-SEP-2018. EXPIRATION DATE: 2023-08-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ANOTHER SIMILAR REPORTED EVENT (COMPLAINT (B)(4)).

    Description of Event or Problem · 1

    REVISION SURGERY 1.5 MONTH AFTER PRIMARY DUE TO HIP INFECTION (THE PATHOGEN IS UNKNOWN). THE SURGEON PERFORMED AN I&D AND REVISED THE CERAMIC HEAD AND POLYETHYLENE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281538 BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE S HIP CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 184381 07630030809194

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention