BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 28/DMD

    MDR report key: 10911231 · Received November 26, 2020

    Report

    Report Number
    3005180920-2020-00829
    Event Type
    Injury
    Date Received
    November 26, 2020
    Date of Event
    October 27, 2020
    Report Date
    November 26, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807244
    PMA / PMN Number
    K092265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 05 NOVEMBER 2020: LOT 2000166: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-APR-2020. EXPIRATION DATE: 2025-03-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH 2 SIMILAR EVENTS REPORTED. ADDITIONAL ITEM INVOLVED IN THE EVENT: BALL HEADS: MECTACER 01.29.202 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M 0 (K112115) LOT. 1905634. BATCH REVIEW PERFORMED ON 26 NOVEMBER 2020: LOT 1905634: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-OCT-2019. EXPIRATION DATE: 2024-09-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ONE SIMILAR EVENT REPORTED ON THE SAME LOT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN, 2 MONTHS AFTER PRIMARY SURGERY, DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1373282 LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 28/DMD DOUBLE MOBILITY HC LINER MEH MEDACTA INTERNATIONAL SA 01.26.2848MHC 2000166 07630030807244

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention