BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 19069588 · Received April 9, 2024

    Report

    Report Number
    3005180920-2024-00214
    Event Type
    Injury
    Date Received
    April 9, 2024
    Date of Event
    March 18, 2024
    Report Date
    April 9, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809200
    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 22 MARCH 2024: LOT 2346007: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-DEC-2023. EXPIRATION DATE: 2028-11-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICES INVOLVED: BATCH REVIEWS PERFORMED ON 22 MARCH 2024. ACETABULAR SHELL: CUP: VERSAFITCUP CC TRIO 01.26.45.0056 ACETABULAR SHELL CC TRIO Ø 56 (K103352) LOT 2209693: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-SEPT-2022. EXPIRATION DATE: 2027-08-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CERAMIC LINER INVOLVED BUT NOT MARKETED IN THE USA: LINER: MECTACER 01.29.414 CERAMIC LINER Ø 36 / F (NO K NUMBER) LOT 2209228: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-JUL-2022. EXPIRATION DATE: 2027-07-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT 1 MONTH FROM THE PRIMARY, REVISION SURGERY DUE TO INSTABILITY. HEAD, CUP AND LINER WERE REMOVED AND REPLACED WITH A CUP THAT ALLOWED FOR A DUAL MOBILITY LINER AND A LONGER HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2288486 MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0 HIP CERAMIC HEAD LZO MEDACTA INTERNATIONAL SA 2346007 07630030809200

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention