BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: VERSAFITCUP DM DOUBLE MOBILITY LINER Ø 48/28

    MDR report key: 8636448 · Received May 23, 2019

    Report

    Report Number
    3005180920-2019-00401
    Event Type
    Injury
    Date Received
    May 23, 2019
    Date of Event
    April 23, 2019
    Report Date
    May 23, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807237
    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 20 MAY 2019: LOT 090083: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-MAR-2009. EXPIRATION DATE: 2014-02-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED IN THE EVENT BALL HEADS: MECTACER 38.39.7175.245.00 BIOLOX FORTE CERAMIC BALL HEAD 12/14 Ø 28 SIZE S -3.5 (USA) (K073337). LOT: 082881: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-OCT-2008. EXPIRATION DATE: 2013-08-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER: VISUAL INSPECTION SHOWS DEFORMATION OF THE INNER SPHERICITY OF THE PE LINER, CAUSING INNER HEAD ROM REDUCTION AND NON CONGRUENT RELATIVE MOVEMENT BETWEEN THE TWO COMPONENTS. THE PE LINER EDGE SHOWS SOME DEFORMATION TOO. IT IS NOT POSSIBLE TO DETERMINE FAILURE ROOT CAUSE.

    Description of Event or Problem · 1

    REVISION SURGERY ABOUT 9 YEARS AND 10 MONTHS AFTER PRIMARY DUE TO GENERIC PAIN. THE REASON OF PAIN IS UNKNOWN. CUP AND STEM LOOKED WELL FIXED. THE SURGERY WAS COMPLETED SUCCESSFULLY, HEAD AND LINER SWAPPED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429074 LINER: VERSAFITCUP DM DOUBLE MOBILITY LINER Ø 48/28 HIP DOUBLE MOBILITY LINER MEH MEDACTA INTERNATIONAL SA 090083 07630030807237

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention