BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: VERSAFITCUP ACETABULAR SHELL Ø 54

    MDR report key: 9334637 · Received November 18, 2019

    Report

    Report Number
    3005180920-2019-00969
    Event Type
    Injury
    Date Received
    November 18, 2019
    Date of Event
    October 22, 2019
    Report Date
    November 18, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030808128
    PMA / PMN Number
    K083116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 25 OCTOBER 2019: LOT 082537: 8 ITEMS MANUFACTURED AND RELEASED ON 11-DEC-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 OTHER SIMILAR REPORTED EVENT. ADDITIONAL DEVICE INVOLVED IN THE COMPLAINT. BATCH REVIEW PERFORMED ON 25 OCTOBER 2019: LINER: VERSAFITCUP DM 01.26.2854M DOUBLE MOBILITY LINER Ø 54/28 (K083116) LOT 082980: 24 ITEMS MANUFACTURED AND RELEASED ON 09-DEC-2008. EXPIRATION DATE: 2013-10-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 23 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN DUE TO A LOOSE CUP THAT WAS CAUSED FROM OSTEOLYSIS. THE SURGEON REVISED THE CUP, LINER, AND HEAD ALMOST 10 YEARS AND 5 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1133020 CUP: VERSAFITCUP ACETABULAR SHELL Ø 54 HIP ACETABULAR SHELL MEH MEDACTA INTERNATIONAL SA 082537 07630030808128

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention