BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: VERSAFITCUP CC TRIO FLAT PE HC LINER Ø 32 / C

    MDR report key: 18266626 · Received December 5, 2023

    Report

    Report Number
    3005180920-2023-00962
    Event Type
    Injury
    Date Received
    December 5, 2023
    Date of Event
    November 9, 2023
    Report Date
    December 5, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807541
    PMA / PMN Number
    K120531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 16 NOVEMBER 2023: LOT 2111759: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-SEP-2021. EXPIRATION DATE: 2026-AUG-31. 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 REVIEW PERFORMED ON 16 NOVEMBER 2023. BALL HEADS: MECTACER 01.29.206 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE L +4 (K112115) LOT 2009397: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-JAN-2021. EXPIRATION DATE: 2026-JAN-07. 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. CUP: VERSAFITCUP CC TRIO 01.26.45.0046 ACETABULAR SHELL CC TRIO Ø 46 (K103352) LOT 2104085: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-JUL-2021. EXPIRATION DATE: 2026-JUL-04. 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

    THE PATIENT CAME IN REPORTING PAIN AND INSTABILITY DUE TO A LEG LENGTH DISCREPANCY. ABOUT 1 YEAR AND 11 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE HEAD, CUP AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2197288 LINER: VERSAFITCUP CC TRIO FLAT PE HC LINER Ø 32 / C HIP SHELL LINER LZO MEDACTA INTERNATIONAL SA 2111759 07630030807541

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Required Intervention