BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: VERSAFITCUP DM DOUBLE MOBILITY LINER Ø 48/28

    MDR report key: 8473652 · Received April 2, 2019

    Report

    Report Number
    3005180920-2019-00228
    Event Type
    Injury
    Date Received
    April 2, 2019
    Date of Event
    March 4, 2019
    Report Date
    April 2, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807237
    PMA / PMN Number
    K083116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 01 APRIL 2019: LOT 083746: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-MAR-2009. EXPIRATION DATE: 2013-12-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICA AFFAIRS DIRECTOR: HIP REVISION SURGERY OCCURRED MORE THAN 9 YEARS AFTER DOUBLE-MOBILITY TOTAL HIP ARTHROPLASTY. A STANDARD POLYETHYLENE DUAL MOBILITY LINER HAD BEEN ORIGINALLY IMPLANTED AND COUPLED WITH A COMPETITOR STEM. SOME WEAR OF A DOUBLE MOBILITY LINER AFTER 9 YEARS IS NORMAL; THE OSTEOLYTIC RESPONSE DEPENDS ON INDIVIDUAL FACTORS. ACCORDING TO THE INFORMATION RECEIVED, THE STEM NECK WAS NOT POLISHED. MEDACTA DOUBLE-MOBILITY CUPS WERE NOT TESTED WHEN COUPLED WITH COMPETITOR STEMS: THEIR BEHAVIOUR CANNOT BE PREDICTED IN THIS CONDITION.

    Description of Event or Problem · 1

    REVISION SURGERY 9.5 YEARS AND A HALF AFTER PRIMARY FOR OSTEOLYSIS. THE SURGEON REVISED CUP AND LINER SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266615 LINER: VERSAFITCUP DM DOUBLE MOBILITY LINER Ø 48/28 HIP DOUBLE MOBILITY LINER MEH MEDACTA INTERNATIONAL SA 083746 07630030807237

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention