BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE L +4

    MDR report key: 17773092 · Received September 19, 2023

    Report

    Report Number
    3005180920-2023-00727
    Event Type
    Injury
    Date Received
    September 19, 2023
    Date of Event
    August 23, 2023
    Report Date
    September 19, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809170
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 30 AUGUST 2023: LOT 2204275: 109 ITEMS MANUFACTURED AND RELEASED ON 19-MAY-2022. EXPIRATION DATE: 2027-05-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 92 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICE INVOLVED BATCH REVIEW PERFORMED ON 30 AUGUST 2023: LINER: MPACT 01.32.3244HCT FLAT PE HC LINER Ø32/E (K103721) LOT 2208320: 33 ITEMS MANUFACTURED AND RELEASED ON 07-JUNE-2022. EXPIRATION DATE: 2027-05-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 29 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 7 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1891676 MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE L +4 HIP CERAMIC HEAD LZO MEDACTA INTERNATIONAL SA 2204275 07630030809170

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention