BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET STEMMED TIBIAL PLATE 75MM ¿ INTERLOK WITH LOCKING BAR / WITH PLUGS

    MDR report key: 6137813 · Received December 1, 2016

    Report

    Report Number
    0001825034-2016-04792
    Event Type
    Injury
    Date Received
    December 1, 2016
    Date of Event
    July 16, 2015
    Report Date
    October 1, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBV
    PMA / PMN Number
    PK010212
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THE REPORTED DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 4 STATES, ¿LOOSENING OR MIGRATION OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION OR EXCESSIVE ACTIVITY.¿ NUMBER 15 STATES, ¿INTEROPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN.¿ CONCOMITANT MEDICAL PRODUCTS - AGC PATELLA ARCOM POLY. WITH WIRE 34MM CATALOG 11-150828 LOT 653030; BMT SPLINED KNEE STM 80X20MM CATALOG 141620 LOT 187910. THIS REPORT IS NUMBER 2 OF 8 MDR'S FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-04791 / 04798).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED [LOCATION UNKNOWN] TO ZIMMER BIOMET FOR INVESTIGATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT 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. 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

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT A RIGHT KNEE REVISION PROCEDURE APPROXIMATELY SEVEN YEARS POST-IMPLANTATION DUE TO ALLEGED PAIN, DYSFUNCTION, AND LOOSENING. A REVIEW OF INVOICE HISTORY CONFIRMS TIBIAL TRAY, PATELLA, BEARING AND FEMUR WERE REMOVED AND REPLACED. 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

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT A RIGHT KNEE REVISION PROCEDURE APPROXIMATELY SEVEN YEARS POST-IMPLANTATION DUE TO ALLEGED PAIN, DYSFUNCTION, NICKEL ALLERGY, LIMITED RANGE OF MOTION AND LOOSENING OF THE FEMORAL COMPONENTS. A REVIEW OF INVOICE HISTORY CONFIRMS TIBIAL TRAY, PATELLA, BEARING AND FEMUR WERE REMOVED AND REPLACED. LEGAL COUNSEL ALSO REPORTED THAT THE PATIENT EXPIRED DUE TO UNKNOWN REASONS APPROXIMATELY ONE MONTH POST REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788972 BIOMET STEMMED TIBIAL PLATE 75MM ¿ INTERLOK WITH LOCKING BAR / WITH PLUGS PROSTHESIS, KNEE MBV BIOMET ORTHOPEDICS N/A 161550

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R