BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TINBN VG INT PS ANAT FM L 60MM

    MDR report key: 7086190 · Received December 6, 2017

    Report

    Report Number
    3002806535-2017-01169
    Event Type
    Malfunction
    Date Received
    December 6, 2017
    Report Date
    April 26, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JWH
    PMA / PMN Number
    PSEE H10
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT HAS BEEN RETURNED TO BIOMET UK LTD FOR EVALUATION. FROM THE PHOTO SUPPLIED, IT CAN BE CONFIRMED THAT A FIBRE / DEBRIS HAS BEEN FOUND IN THE PACKAGING. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. NO SIMILAR COMPLAINTS HAVE BEEN FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). (B)(4). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE DISTRIBUTOR HAS FOUND DEBRIS IN THE PACKAGING AT THEIR INTERNAL INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    867353 TINBN VG INT PS ANAT FM L 60MM KNEE PROSTHESIS JWH BIOMET UK LTD. N/A 6079183

    Patients

    Seq Age Sex Outcome Treatment
    1