BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO 52

    MDR report key: 12023462 · Received June 18, 2021

    Report

    Report Number
    3005180920-2021-00496
    Event Type
    Injury
    Date Received
    June 18, 2021
    Date of Event
    May 19, 2021
    Report Date
    June 18, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807770
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 26 MAY 2021 LOT 1811152: 320 ITEMS MANUFACTURED AND RELEASED ON 21-MAR-2019. EXPIRATION DATE: 2024-03-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 196 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. CLINICAL EVALAUTION PERFORMED BY MEDICAL AFFAIRS MANAGER: ACETABULAR COMPONENT REVISION PERFORMED 2 YEARS AFTER PRIMARY CEMENTLESS TOTAL HIP ARTHROPLASTY IN A (B)(6) YEAR OLD WOMAN. ACCORDING TO THE REPORT, THE PATIENT REPORTED PAIN. NO CONCLUSION CAN BE DRAWN FROM THE SINGLE ANTEROPOSTERIOR RADIOGRAPHIC IMAGE PROVIDED. THE REASON OF THIS EVENT CANNOT BE DETERMINED ADDITIONAL ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 26 MAY 2021 BALL HEADS: MECTACER 01.29.205 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M 0 (K112115) LOT. 1810797 LOT 1810797: 320 ITEMS MANUFACTURED AND RELEASED ON 11-MAR-2019. EXPIRATION DATE: 2024-02-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 317 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. LINER: MECTACER 01.29.410 CERAMIC LINER Ø 32 / E LOT. 1810814 (THE ITEM IS NOT REGISTERED IN USA) LOT 1810814: 227 ITEMS MANUFACTURED AND RELEASED ON 07-MAR-2019. EXPIRATION DATE: 2024-02-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 221 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    HIP REVISION SURGERY PERFORMED ON THE RIGHT SIDE FOLLOWING ANTERIOR PAIN ONLY, NO INFECTION OR IMPLANT LOOSENING. CUP, LINER AND HEAD HAVE BEEN SUCCESSFULLY REVISED 1 YEAR AND 11 MONTHS AFTER PRIMARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920930 CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO 52 ACETABULAR SHELL LZO MEDACTA INTERNATIONAL SA 01.26.45.0052 1811152 07630030807770

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention