BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXF TRL BRG W/SLOTS MED 3MM

    MDR report key: 13024656 · Received December 17, 2021

    Report

    Report Number
    3002806535-2021-00530
    Event Type
    Malfunction
    Date Received
    December 17, 2021
    Date of Event
    December 13, 2021
    Report Date
    October 25, 2022
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    UDI-DI
    05019279346813
    PMA / PMN Number
    P010014
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D4, D9, G3, G6, H1, H2, H3, H4, H6, H10. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED THE BEARING WAS INTACT WITH A PARTIAL FRACTURE ON ONE CORNER. THE BEARING ALSO SHOWED GENERAL WEAR AND TEAR. THE BEARING HAS POTENTIALLY BEEN IN THE FIELD FOR 3 YEARS AND 8 MONTHS. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT 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.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY SUPPLEMENTAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H1, H2, H6, AND H10. COMPLAINT SUMMARY: ADEQUATE PHOTOGRAPHS HAVE NOT BEEN PROVIDED AND THE PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, THE INVESTIGATION HAS BEEN LIMITED TO THE INFORMATION PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS, AND A COMPLAINT HISTORY SEARCH. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING THAT COULD BE RELATED TO THE REPORTED EVENT. THIS DEVICE IS USED FOR TREATMENT. THE REPORTED EVENT IS NOT RELATED TO A COMBINATION OF PRODUCTS; THEREFORE, A COMPATIBILITY REVIEW IS NOT APPLICABLE. A REVIEW OF COMPLAINT HISTORY IDENTIFIED 8 ADDITIONAL SIMILAR COMPLAINTS ABOUT THE REPORTED ITEM AND NO ADDITIONAL COMPLAINTS ABOUT THE REPORTED ITEM AND LOT COMBINATION. MEDICAL RECORDS OR X-RAYS HAVE NOT BEEN PROVIDED AS THERE WAS NO PATIENT HARM. THE LIKELY CONDITION OF THE DEVICE WHEN IT LEFT ZIMMER BIOMET IS CONFORMING TO THE SPECIFICATION. THE REPORTED EVENT HAS NOT BEEN CONFIRMED AS RELEVANT PHOTOGRAPHS HAVE NOT BEEN PROVIDED AND THE PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION AND THE DHR REVIEW DID NOT IDENTIFY ANY ISSUES. THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. IT HAS BEEN CONFIRMED THAT THE INSTRUMENT IS NOT WITHIN THE SCOPE OR SUBJECT OF ANY FIELD ACTIONS OR RECALLS WHICH COULD BE ATTRIBUTED TO THE REPORTED EVENTS. IF ANY ADDITIONAL INFORMATION IS DISCOVERED OR RECEIVED THAT MAY ADJUST ANY CONCLUSIONS OR DATA, A SUPPLEMENTAL REPORT WILL BE RENDERED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). INITIAL REPORT. REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED, THAT: WHEN THEY TOOK OUT THE POLY WITH THE « THIS SIDE UP » DEVICE IN THE OXFORD INSTRUMENTS, THE TRIAL POLY CRACKED ON THE BOTTOM SIDE. IT CANNOT BE STERILIZED. PATIENT OUTCOME: NO FURTHER INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: WHEN THEY TOOK OUT THE POLY WITH THE « THIS SIDE UP » DEVICE IN THE OXFORD INSTRUMENTS, THE TRIAL POLY CRACKED ON THE BOTTOM SIDE. IT CANNOT BE DESTERILIZED. PATIENT OUTCOME - NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1926545 OXF TRL BRG W/SLOTS MED 3MM BMET GENERAL KNEE INSTRUMENTS NRA BIOMET UK LTD. N/A ZB180505 05019279346813

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown