BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP CC PE ACETABULAR INSERT Ø 36 / F

    MDR report key: 5289453 · Received December 11, 2015

    Report

    Report Number
    3005180920-2015-00323
    Event Type
    Injury
    Date Received
    December 11, 2015
    Date of Event
    November 12, 2015
    Report Date
    March 10, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 11 DECEMBER 2015: LOT 151090: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07 JULY 2015. EXPIRATION DATE: 2020-05-31. 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 MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE L CODE 01.29.210 LOT. 150459 (K112115): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10 APRIL 2015. EXPIRATION DATE: 2020-02-29. 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. NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    ON 10 FEBRUARY 2016, IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON THE SAME DATE, THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO INSTABILITY/DISLOCATION. LINER AND HEAD EXCHANGED. NO PIECES AVAILABLE, NO X-RAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818496 VERSAFITCUP CC PE ACETABULAR INSERT Ø 36 / F ACETABULAR PE LINER LZO MEDACTA INTERNATIONAL SA 151090

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention