BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPRLC 133 TYPE1 PPS HO 11.0

    MDR report key: 3755268 · Received April 17, 2014

    Report

    Report Number
    0001825034-2014-02973
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    March 18, 2014
    Report Date
    February 6, 2015
    Manufacturer
    BIOMET U.K. LTD
    Product Code
    JDI
    PMA / PMN Number
    PK0101086
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. DEVICE RETURNED TO MANUFACTURER ON (B)(4) 2014. HOWEVER, AS ALL THE PACKAGING WAS NOT RETURNED, THIS WOULD BE THE BLISTER, TOP /BOTTOM FOAM, TYVEK LID, IFU, BOX AND SLEEVE IT HAS PROVED DIFFICULT TO ASCERTAIN THE EXACT FAILURE POINT. WITHOUT THE OFFENDING PACKING MATERIALS IT IS DIFFICULT TO ASSES THE EXACT CAUSE OF THE REPORTED ISSUE. THE SEALS ARE CONTINUALLY CHECKED THROUGHOUT THE PACKING PROCESS AS ARE THE MACHINES USED TO SEAL THE POUCHES AND BLISTERS. DURING EVALUATION OF THE TYVEK LID THERE SEEMS TO BE ADHESIVE ON THE TYVEK BUT NO RESIDUE ON THE BLISTER. THIS INDICATES EITHER FULL CONTACT BETWEEN THE LID AND THE BLISTER WERE NOT MADE WHEN SEALING OR FOR SOME REASON DETERIORATION OF THE SEAL HAPPENED AFTER PACKING. ALL CALIBRATION AND BURST TEST/PEEL TEST DETAILS CONFIRM THAT THERE WERE NO PROBLEMS ON THE SEALING EQUIPMENT FOR BLISTER JV540076/LID JV540077 COMBINATION. THE PRODUCT WAS PACKED BY A TRAINED OPERATOR. THE PRODUCT WAS CONFORMING WHEN LEAVING BIOMET.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. PRODUCT IS BEING RETURNED TO MANUFACTURER, BUT HAS NOT YET BEEN RECEIVED. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA.

    Additional Manufacturer Narrative · 1

    BASED ON THE PICTURES, THE COMPLAINT IS CONFIRMED THAT THE TYVEK LID HAD LOST ITS ADHESION TO THE TRAY. THIS IS NOT DUE TO A SEALING ISSUE, AS THE DIFFERENT FINISHES OF THE ADHESIVE ON THE LID INDICATE THAT A GOOD SEAL WAS APPLIED TO THE TRAY/LID. THE CONDITION IS ACTUALLY DUE TO A COMBINATION OF THE TRAY/LID MATERIALS, GAMMA STERILIZATION, AND EXTREME ENVIRONMENTAL CONDITIONS. THE THIRD ONE BEING THAT KEY AS IT OCCURS RARELY IN THE TRADITIONAL SHIPPING ENVIRONMENT. THIS IS THE FIRST KNOWN COMPLAINT OF THIS TYPE OF ISSUE, BUT THE CONDITION HAS BEEN DUPLICATED DURING PACKAGING PERFORMANCE VALIDATIONS AND THE EXTREME ENVIRONMENTAL CONDITIONING COMPLETED PER ISTA 2A. THE PRODUCT WAS CONFORMING WHEN LEAVING BIOMET.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2014. DURING THE PROCEDURE WHEN OPENING THE STERILE PACKAGE, THE SEAL OF THE BLISTER TRAY WAS INCOMPLETE AND THE TYVEK LID FELL OFF AND DIDN'T REQUIRE PEELING. DEVICE WAS DETERMINED NOT TO BE STERILE AND WAS NOT IMPLANTED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235500 TPRLC 133 TYPE1 PPS HO 11.0 PROSTHESIS, HIP JDI BIOMET U.K. LTD N/A 3223406

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R