BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXFORD UNI TIB TRAY SZ B RM PMA

    MDR report key: 19981271 · Received August 14, 2024

    Report

    Report Number
    3002806535-2024-00292
    Event Type
    Malfunction
    Date Received
    August 14, 2024
    Date of Event
    July 26, 2024
    Report Date
    September 11, 2024
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    UDI-DI
    05019279388875
    PMA / PMN Number
    P010014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. 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 COMMUNICATIONS WITH OUR CHINA COMMERCIAL OFFICE THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED DISTRIBUTION WHERE THE THIRD PARTY DISTRIBUTOR SUPPLIED AN OPENED PRODUCT TO THE HOSPITAL IN ERROR. NO CORRECTIVE, PREVENTIVE OR FIELD ACTION WAS TAKEN FOLLOWING THE INVESTIGATION OF THIS EVENT, HOWEVER BASED ON THE COMMUNICATIONS WITH OUR CHINA COMMERCIAL OFFICE, THE THIRD PARTY DISTRIBUTOR HAS BEEN INFORMED BY ZIMMER BIOMET CHINA THAT THEY WILL NEED TO STORE OPENED PRODUCTS IN A SEPARATE AREA FROM UNOPENED PRODUCTS IN THE FUTURE. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE, IT WAS FOUND THAT THE PLASTIC PACKAGING INSIDE THE CARTON WAS NOT SEALED, INDICATING THAT THE STERILE BARRIER HAD BEEN BREACHED AND COULD NOT BE USED ON THE PATIENT. THE SURGERY WAS COMPLETED WITH ANOTHER DEVICE. IT WAS EVENTUALLY CONFIRMED THAT INITIALLY, THE DISTRIBUTOR ACCIDENTALLY SENT THE HOSPITAL A PRODUCT WHICH THEY HAD ALREADY OPENED. THIS WAS CLARIFIED WITH THE HOSPITAL AND SURGEON. THIS EVENT 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264871 OXFORD UNI TIB TRAY SZ B RM PMA KNEE PROSTHESIS NRA BIOMET UK LTD. 7252976 05019279388875

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Female