BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: VERSAFITCUP DOUBLE MOBILITY HC 48/28

    MDR report key: 12531972 · Received September 27, 2021

    Report

    Report Number
    3005180920-2021-00778
    Event Type
    Injury
    Date Received
    September 27, 2021
    Date of Event
    August 30, 2021
    Report Date
    September 27, 2021
    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 09 SEPTEMBER 2021: LOT 1908425: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-GEN-2020. EXPIRATION DATE: 2025-01-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ANOTHER DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 09 SEPTEMBER 2021: STEM: AMISTEM P 01.18.403 AMISTEM-P STD STEM SIZE 3 (K173794) LOT 1907040: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-DEC-2019. EXPIRATION DATE: 2024-11-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. BALL HEADS: MECTACER 01.29.201 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE S -3.5 (K112115) LOT 1906461: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-OTT-2019. EXPIRATION DATE: 2014-10-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING INSTABILITY DUE TO A LEG LENGTH DISCREPANCY AND THE CAUSE IS UNKNOWN. 1 YEAR AND 2 MONTHS AFTER PRIMARY THE SURGEON REVISED THE STEM, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1431533 LINER: VERSAFITCUP DOUBLE MOBILITY HC 48/28 DOUBLE MOBILITY LINER MEH MEDACTA INTERNATIONAL SA 01.26.2848MHC 1908425 07630030807244

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention