BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0

    MDR report key: 16944412 · Received May 17, 2023

    Report

    Report Number
    3005180920-2023-00377
    Event Type
    Injury
    Date Received
    May 17, 2023
    Date of Event
    April 27, 2023
    Report Date
    May 17, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809200
    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 (B)(6) 2023: LOT 125387: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JAN-2013. EXPIRATION DATE: 2017-12-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICE INVOLVED BATCH REVIEW PERFORMED ON (B)(6) 2023: LINER: MPACT 01.32.3652HCAT HOODED PE HC LINER Ø36/G (K132879) LOT 133706: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-OTT-2013. EXPIRATION DATE: 2018-08-31. 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.

    Description of Event or Problem · 0

    AT ABOUT 8 YEARS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542165 MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0 HIP CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 01.29.209 125387 07630030809200

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention