BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCK MAXIMUM CONGRUENT KNEE) KNEE SYSTEM - BMT SPLINED KNEE STM 14X120

    MDR report key: 6451230 · Received March 31, 2017

    Report

    Report Number
    0001825034-2017-02312
    Event Type
    Injury
    Date Received
    March 31, 2017
    Date of Event
    February 23, 2017
    Report Date
    April 26, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK915132
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: OSS TIBIAL POLY BEARING 12MM, CATALOG 150410, LOT 133060; FINN AXLE, CATALOG 153872, LOT 241730; OSS REINFORCED YOKE, CATALOG 150479, LOT 265640; OSS PROXIMAL TIBIA 5CM 9X150, CATALOG 150435, LOT 428620; FINN FEMORAL BUSHINGS (SET OF 2), CATALOG 153852, LOT 234670; FINN TIBIAL BUSHING, CATALOG 153851, LOT 221230; FINN LOCK PIN, CATALOG 153861, LOT 387160; FINN FEMUR RIGHT, CATALOG 153801, LOT 129390; BIOMET ARCOM PATELLA 34MM, CATALOG CP102888, LOT 185820. 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: 1825034-2017-01365, 1825034-2017-02313, 1825034-2017-02314, 1825034-2017-02315, 1825034-2017-02316, 1825034-2017-02317, 1825034-2017-02318.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS BEEN INDICATED FOR A KNEE REVISION OF ORTHOPEDIC SALVAGE COMPONENTS DUE TO UNKNOWN REASONS APPROXIMATELY 16 YEARS POST IMPLANTATION. ADDITIONAL INFORMATION RECEIVED CONFIRMED THE PATIENT WAS REVISED. ALL COMPONENTS BUT THE FEMUR WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233559 MCK MAXIMUM CONGRUENT KNEE) KNEE SYSTEM - BMT SPLINED KNEE STM 14X120 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS 211630 

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R