BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP CC TRIO 01.26.45.0050 ACETABULAR SHELL CC TRIO Ø 50

    MDR report key: 12874311 · Received November 25, 2021

    Report

    Report Number
    3005180920-2021-00931
    Event Type
    Injury
    Date Received
    November 25, 2021
    Date of Event
    November 3, 2021
    Report Date
    November 25, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807763
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 09 NOVEMBER 2021. LOT 2011614: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-MAR-2021. EXPIRATION DATE: 2026-MAR-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT. OTHER DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 09 NOVEMBER 2021. AMISTEM P 01.18.404 AMISTEM-P STD STEM SIZE 4 (K173794) LOT 2101349: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-MAR-2021. EXPIRATION DATE: 2026-MAR-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT. MECTACER 01.29.209 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0 (K112115) LOT 2012922: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-APR-2021. EXPIRATION DATE: 2026-MAR-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.

    Description of Event or Problem · 0

    REVISION SURGERY WAS PERFORMED 2 MONTHS AND A HALF AFTER THE PRIMARY SURGERY DUE TO INFECTION. CUP, LINER, HEAD, AND STEM REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1773697 VERSAFITCUP CC TRIO 01.26.45.0050 ACETABULAR SHELL CC TRIO Ø 50 ACETABULAR SHELL LZO MEDACTA INTERNATIONAL SA 01.26.45.0050 2011614 07630030807763

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other