BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET COCR FINNED TIB TRAY 67 MM

    MDR report key: 8767356 · Received July 8, 2019

    Report

    Report Number
    0001825034-2019-02899
    Event Type
    Injury
    Date Received
    July 8, 2019
    Date of Event
    June 11, 2019
    Report Date
    December 12, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K171054
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF PHOTOGRAPH AND X-RAYS. THE PICTURE PROVIDED SHOWS SUBCUTANEOUS BULGING. VISUAL EXAMINATION OF THE RETURNED LOCKING BAR SHOWS SIGNS OF SURFACE SCRATCHES AND NICKS. THE LOCKING BAR WAS SUBMITTED FOR FURTHER ANALYSIS. THE LOCKING BAR SURFACE SHOWS MINIMAL CONTACT ARTIFACTS WITHIN THE OVERLAY REGION AND THE CLASP ALSO SHOWS MINIMAL CONTACT ARTIFACTS. THE EXAMINED LOCKING BAR CONTACT MARKS AND DEFORMATION ARE CONSISTENT WITH THE BAR NOT BEING FULLY ENGAGED WITH THE TIBIAL TRAY LUGS; HOWEVER, IT CANNOT BE DETERMINED WHETHER THE REPORTED LOCKING BAR DISSOCIATION OCCURRED DUE TO IMPROPER INSERTION. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE 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.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: VNGD ANT STBLZD BRG 10X67, CATALOG#: 189040, LOT#: 963800. UNKNOWN BIOMET FEMORAL, CATALOG#: NI, LOT#: NI. UNKNOWN BIOMET TIBIAL TRAY, CATALOG#: NI, LOT#: NI. (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT LEFT KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO DISCOMFORT AND SWELLING FROM LOCKING BAR BACKING OUT APPROXIMATELY ONE YEAR POST OPERATIVELY. THE LOCKING BAR AND BEARING WERE REPLACED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562245 BIOMET COCR FINNED TIB TRAY 67 MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A J61559913

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R