BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP DOUBLE MOBILITY HC LINER

    MDR report key: 2096684 · Received May 5, 2011

    Report

    Report Number
    3005180920-2011-00022
    Event Type
    Injury
    Date Received
    May 5, 2011
    Date of Event
    April 12, 2011
    Report Date
    May 5, 2011
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    PMA / PMN Number
    K092265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACETABULAR LINER WAS JUST RECEIVED AND IT WILL BE ANALYZED. DOCUMENT REVIEW: VERSAFITCUP DM HC LINER REF. (B)(4)/LOT. 091558. ALL PARAMETERS WERE FOUND TO BE CONFORMING TO SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. THE WASHING CYCLES FOR PLASTIC COMPONENTS WERE RUN ACCORDING TO SPECIFICATIONS AND NO ALARM OR DEVIATION OCCURRED DURING OPERATION. THE STERILIZATION CYCLES WERE PERFORMED ACCORDING TO SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. FORTY ONE LINERS BELONGING TO THIS LOT (TOTAL 46 PCS) HAVE BEEN IMPLANTED AND NO INCIDENTS HAVE BEEN REPORTED UP TO NOW. AMISTEM H FEM STEM SIZE 4 - REF. (B)(4)/LOT. 100539. COCR BALL HEAD 28 M - REF. (B)(4)/LOT. 100528. ALL PARAMETERS WERE FOUND TO BE CONFORMING TO SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. THE WASHING CYCLES FOR METAL COMPONENTS WERE RUN ACCORDING TO SPECIFICATIONS AND NO ALARM OR DEVIATION OCCURRED DURING OPERATION. THE STERILIZATION CYCLES WERE PERFORMED ACCORDING TO SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. (B)(4). THE REVISION SURGERY IS ASSOCIATED TO AN INFECTION EVENT. ON THE BASIS OF THE BATCH RECORDS REVIEW AND THE ABSENCE OF INFECTION EVENTS ON THE OTHER PIECES OF THE SAME LOTS, A DEVICE INVOLVEMENT IS HIGHLY UNLIKELY.

    Description of Event or Problem · 1

    PT HAD LATERAL THIGH PAIN DUE TO MICROMOTION OF THE FEMORAL STEM AS THE PROXIMAL 2/3RDS WERE NOT FIXED. THE PRE-OPERATIVE PLAN WAS TO REVISE THE STEM AND HEAD WITH PROXIMAL FIXATION, BUT DURING SURGERY, THE HC LINER WAS YELLOW DUE TO BACTERIAL INFECTION. REVISED HC LINER AND USED THE EXPLANTED FEMORAL STEM TO CREATE THE ANTIBIOTIC BONE CEMENT SPACER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSAFITCUP DOUBLE MOBILITY HC LINER ACETABULAR HC PE LINER MEH MEDACTA INTERNATIONAL SA 091558

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention COCR BALL HEAD 28 SIZE M: REF. (B)(4)| LOT. 100528| LOT. 100539| AMISTEM H FEM STD SIZE 4: REF. (B)(4)