BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET TIBIAL TRAYS - CC CRUCIATE TRAY 83MM

    MDR report key: 6432521 · Received March 24, 2017

    Report

    Report Number
    0001825034-2017-02067
    Event Type
    Injury
    Date Received
    March 24, 2017
    Date of Event
    July 11, 2016
    Report Date
    December 21, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK142933
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS ¿ VANGUARD PS FEMUR RIGHT 75 MM, CATALOG: 183114, LOT: 217460; BIOMET CRUCIATE TRAY 83 MM, CATALOG: 141236, LOT: J3164690; VANGUARD PS FEMUR LEFT 75 MM, CATALOG: 183134, LOT: 060840; VANGUARD PS TIBIAL BEARING 79/83 MM X 10 MM, CATALOG EP-183660, LOT: 923770; VANGUARD PS TIBIAL BEARING 79/83 MM X 10 MM, CATALOG: EP-183660, LOT: 644360; SERIES A PATELLA 34 MM, CATALOG: 184766, LOT: 236760; SERIES A PATELLA 34 MM, CATALOG: 184766, LOT: 914120. CUSTOMER HAS NOT INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. 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: 1825034-2017-02066, 1825034-2017-02068, AND 1825034-2017-02069.

    Additional Manufacturer Narrative · 1

    UPON RECEIVING ADDITIONAL INFORMATION ON THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS THE PATIENT WAS ALLERGIC TO THE FEMORAL COMPONENT. THE TIBIAL TRAY WAS TITANIUM.

    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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE TIBIAL IMPLANT WAS NOT REMOVED DURING THIS EVENT. REPORTED EVENT WAS CONFIRMED THROUGH REVIEW OF MEDICAL RECORDS. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND TO BE RELATED WITH THIS EVENT. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. SURGICAL NOTES WERE PROVIDED FOR THE REVISION SURGERY. REVIEW OF THE REVISION OPERATIVE NOTES INDICATES THAT THE SURGEON NOTED NO COMPLICATIONS. THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO PATIENT'S CONDITION AS PATIENT WAS REPORTED TO HAVE A METAL ALLERGY. 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 BY THE PATIENT¿S LEGAL COUNSEL THAT THE PATIENT UNDERWENT BILATERAL KNEE ARTHROPLASTIES APPROXIMATELY THREE YEARS AGO AND WAS REVISED ON AN UNKNOWN DATE DUE TO PATIENT ALLEGATIONS OF METAL ALLERGIES. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT¿S LEGAL COUNSEL THAT THE PATIENT UNDERWENT BILATERAL KNEE ARTHROPLASTIES APPROXIMATELY THREE YEARS AGO. SUBSEQUENTLY THE PATIENT WAS REVISED DUE TO PAIN, EFFUSIONS AND METAL ALLERGIES. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213215 BIOMET TIBIAL TRAYS - CC CRUCIATE TRAY 83MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS J3227477

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R