BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET COCR FINNED TIB TRAY 67 MM

    MDR report key: 6543457 · Received May 4, 2017

    Report

    Report Number
    0001825034-2017-02971
    Event Type
    Injury
    Date Received
    May 4, 2017
    Date of Event
    July 15, 2015
    Report Date
    November 20, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK142933
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO NOT BE REPORTABLE. THERE ARE NO ALLEGATIONS OF FAILURE OF THE DEVICE AND THE INITIAL REPORT WAS SUBMITTED IN ERROR

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT NUMBER CORRESPONDING TO THIS MEDWATCH IS CMP-(B)(4). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS:0001825034-2017-01253, 0001825034-2017-02971, 0001825034-2017-02974 & 0001825034-2017-02976.

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE REPORTS: 0001825034-2017-02971; 0001825034-2017-02971-1; 0001825034-2017-02971-2; 0001825034-2017-01253; 0001825034-2017-01253-1; 0001825034-2017-01253-2; 0001825034-2017-01253-3; 0001825034-2017-02976; 0001825034-2017-02976-1; 0001825034-2017-02976-2; 0001825034-2017-02974; 0001825034-2017-02974-1; 0001825034-2017-02974-2. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: P/N 183132 VAN PS OPEN INTL FEM-LT 70 L/N 049170; P/N 141232 BIOMET COCR FINNED TIB TRAY 67 MM L/N J3477544; P/N 183720 VNGD PS+ TIB BRG 10X63/67MM L/N 665080; P/N 184764 SERIES A PAT STD 31 3 PEG L/N 014690. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. EVENT DATE UNKNOWN. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 · 1

    IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE HAS BEEN INDICATED FOR REVISION TWO YEARS POST-IMPLANTATION DUE TO PAIN AND STIFFNESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ALLEGED TO PAIN AND STIFFNESS TWO YEARS POST-IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326790 BIOMET COCR FINNED TIB TRAY 67 MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A J3477544

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other