BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP CC ACETABULAR INSERT

    MDR report key: 7734730 · Received July 31, 2018

    Report

    Report Number
    3005180920-2018-00600
    Event Type
    Injury
    Date Received
    July 31, 2018
    Date of Event
    July 12, 2018
    Report Date
    July 31, 2018
    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 · 1

    ON (B)(6) 2018 IT WAS COMMUNICATED THAT THE CU WAS TOO ANTEVERTED, MALPOSITIONED DURING THE PRIMARY SURGERY. BATCH REVIEWS PERFORMED ON 30 JULY 2018: LOT 174483: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19 OCTOBER 2017. EXPIRATION DATE: 2022-10-04. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. BATCH REVIEW FOR MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M REF. 01.29.205 LOT. 164976 (K112115): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04 NOVEMBER 2016. EXPIRATION DATE: 2021-10-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ONE SIMILAR REPORTED EVENT. BATCH REVIEW FORVERSAFITCUP CC TRIO ACETABULAR SHELL Ø 48 REF. 01.26.45.0048 LOT. 151056 (K103352): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 MAY 2015. EXPIRATION DATE: 2020-04-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON DETERMINED THAT THE PATIENT HAD DISLOCATED. THE SURGEON REVISED THE CUP, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577087 VERSAFITCUP CC ACETABULAR INSERT ACETABULAR PE LINER LZO MEDACTA INTERNATIONAL SA 174483 07630030807541

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention