BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 52

    MDR report key: 18266624 · Received December 5, 2023

    Report

    Report Number
    3005180920-2023-00931
    Event Type
    Malfunction
    Date Received
    December 5, 2023
    Date of Event
    November 8, 2023
    Report Date
    December 21, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807770
    PMA / PMN Number
    K103352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED BY R&D MANAGER: THE LINERS AND SHELL WERE TESTED IN ORDER TO EVALUATE THE COMPATIBILITY: THE INSERTION WAS PERFORMED CORRECTLY WITHOUT SIGNS OF INCOMPATIBILITY. FROM THE RECEIVED PIECES AND INFORMATION IT IS NOT POSSIBLE TO DETERMINE WITH CERTAINTY THE ROOT CAUSE OF THE EVENT, BUT IT IS POSSIBLE THAT THE PRESENCE OF A LIQUID OR OTHER TISSUES WAS PRESENT IN THE SHELL DURING THE IMPACTION.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 10 NOVEMBER 2023. LOT 2309931: 32 ITEMS MANUFACTURED AND RELEASED ON 18-JUL-2023. EXPIRATION DATE: 2028-07-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 21 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 10 NOVEMBER 2023. LINER: VERSAFITCUP CC TRIO 01.26.3244HCAT HOODED PE HC FIXED LINER Ø 32 / E (K103352) LOT 2311948: 88 ITEMS MANUFACTURED AND RELEASED ON 13-JUL-2023. EXPIRATION DATE: 2028-06-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 63 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. LINER: VERSAFITCUP CC TRIO 01.26.3244HCAT HOODED PE HC FIXED LINER Ø 32 / E (K103352) LOT 2310226: 88 ITEMS MANUFACTURED AND RELEASED ON 08-AUG-2023. EXPIRATION DATE: 2028-07-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 55 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    DURING SURGERY, THE HOODED PE HC FIXED LINER Ø 32 COULDN'T BE CLIPPED INTO THE CUP. THE SAME PROBLEM HAPPENED WITH ANOTHER HOODED PE HC FIXED LINER Ø 32 FROM A DIFFERENT LOT. THE SURGEON DECIDED TO REMOVE THE CUP AND IMPLANTED A NATIVE CEMENTED CUP TO COMPLETE THE SURGERY. DELAY TIME 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2197286 CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 52 HIP ACETABULAR CEMENTLESS SHELL LZO MEDACTA INTERNATIONAL SA 2309931 07630030807770

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Other