BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXFORD UNI CMNTLS TIB SZ B RM

    MDR report key: 19689271 · Received July 8, 2024

    Report

    Report Number
    3002806535-2024-00255
    Event Type
    Malfunction
    Date Received
    July 8, 2024
    Date of Event
    May 7, 2024
    Report Date
    November 8, 2024
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    UDI-DI
    00887868354724
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G2 - FOREIGN: DENMARK. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE PLASTIC POUCH WAS RETURNED AND VISUALLY ASSESSED. IT WAS OBSERVED TO HAVE IMPERFECTIONS AND IS NO LONGER VACUUM SEALED. THE IMPLANT MOVES AROUND FREELY INSIDE THE PLASTIC POUCH AND THIS MOVEMENT APPEARS TO HAVE CAUSED ABRASION OF THE POUCH FROM THE ROUGH, POROUS COATING. BECAUSE THERE IS NO VACUUM OBSERVED, IT IS EVIDENT THAT THE POUCH HAS BEEN COMPROMISED. IT SHOULD BE NOTED THAT THE CARDBOARD BOX AND BLISTER WERE NOT RETURNED FOR EVALUATION AND SO IT WAS NOT POSSIBLE TO ASCERTAIN ANY LEVEL OF DAMAGE TO THE OUTER PACKAGING WHICH MIGHT ALSO HAVE BEEN PRESENT WHICH MIGHT HAVE ENABLED A ROOT CAUSE TO BE ESTABLISHED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. REVIEW OF THE COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. BASED ON THE AVAILABLE INFORMATION, THE REPORTED EVENT CAN BE CONFIRMED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE, THE NURSE NOTICED TWO SMALL PUNCTURE HOLES IN THE INNER STERILE PLASTIC BAG THAT CONTAINS THE TIBIAL IMPLANT. THEY DIDN'T FEEL SAFE USING THE IMPLANT AS THE STERILITY MIGHT BE COMPROMISED. THEY CHANGE GLOVES AND UNWRAP A NEW IMPLANT WITH NO HOLES AND COMPLETED THE SURGERY WITHOUT ANY COMPLICATIONS. THIS INCIDENT IS RELATED TO A MALFUNCTION THAT COULD POTENTIALLY LEAD TO A STERILITY ISSUE OR SERIOUS INJURY. HOWEVER, NO PATIENT HARM OR FURTHER OUTCOME WAS REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151560 OXFORD UNI CMNTLS TIB SZ B RM KNEE PROSTHESIS NRA BIOMET UK LTD. 7605164 00887868354724

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female