BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP DM DOUBLE MOBILITY LINER Ø 58/28

    MDR report key: 7629549 · Received June 22, 2018

    Report

    Report Number
    3005180920-2018-00449
    Event Type
    Injury
    Date Received
    June 22, 2018
    Date of Event
    May 24, 2018
    Report Date
    June 22, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807435
    PMA / PMN Number
    K083116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 19 JUNE 2018; LOT 093130: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11 DECEMBER 2008. EXPIRATION DATE:2013-10-31; 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. OTHER DEVICE INVOLVED: MECTACER BIOLOX FORTE CERAMIC BALL HEAD 12/14 Ø 28 SIZE L +3.5 (USA) REFERENCE 38.39.7175.265.00 (K073337); LOT 083366: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19 NOVEMBER 2008. EXPIRATION DATE: 2013-10-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    ABOUT 9 YEARS AFTER PRIMARY THE PATIENT WAS REVISED FOR GENERIC HIP PAIN. THE SURGEON SWAPPED SUCCESSFULLY THE HEAD AND THE LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473628 VERSAFITCUP DM DOUBLE MOBILITY LINER Ø 58/28 DOUBLE MOBILITY LINER MEH MEDACTA INTERNATIONAL SA 083130 07630030807435

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention