BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: VERSAFITCUP ACETABULAR SHELL Ø 52

    MDR report key: 8673857 · Received June 6, 2019

    Report

    Report Number
    3005180920-2019-00440
    Event Type
    Injury
    Date Received
    June 6, 2019
    Date of Event
    May 8, 2019
    Report Date
    June 6, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030808098
    PMA / PMN Number
    K083116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 03 JUN 2019: LOT 050751: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-NOV-2005. EXPIRATION DATE: 2010-08-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL IMPLANTS INVOLVED: LINER: VERSAFITCUP DM 01.26.2852M DOUBLE MOBILITY LINER Ø 52/28 (K083116) LOT 051580: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-NOV-2005. EXPIRATION DATE: 2010-10-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. BALL HEADS: COCR 01.25.011 COCR BALL HEAD 12/14 Ø 28 SIZE S -3.5 (K072857) LOT 070959: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-JUN-2007. EXPIRATION DATE: 2012-05-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2019 WE WERE INFORMED ABOUT A REVISION SURGERY PERFORMED ON THE FOLLOWING DAY, AFTER ABOUT 12 YEARS FROM THE PRIMARY, DUE TO CUP LOOSENING AND LUXATION OF THE HEAD FROM THE LINER. NO INFORMATION ABOUT THE HEAD, IF CERAMIC OR CRCO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470136 CUP: VERSAFITCUP ACETABULAR SHELL Ø 52 ACETABULAR SHELL MEH MEDACTA INTERNATIONAL SA 050751 07630030808098

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention