BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPRESS ANCHOR PLUG

    MDR report key: 7431239 · Received April 13, 2018

    Report

    Report Number
    0001825034-2018-02646
    Event Type
    Injury
    Date Received
    April 13, 2018
    Report Date
    June 27, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    PMA / PMN Number
    PK031804
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT: COMPRESS BOLT CONCENTRIC CLAMP, CATALOG #: CP110351, LOT #: 113830; SMALL COMPRESS PROXIMAL TIBIAL SPINDLE, CATALOG #: CP110352, LOT #: 113870; COMPRESS CLAMP TIBIAL, CATALOG #: CP110501, LOT #: 111070; LIGAMENT ANCHOR WASHER WITH SCREW, CATALOG #: CP160110, LOT #: 114410; TIBIAL ANCHOR SCREW, CATALOG #: CP160232, LOT #: 114440; BELLEVILLE WASHER SET, CATALOG #: PM550754, LOT #: 114390; COMPRESS NUT, CATALOG #: RD125050, LOT #: 706360; TRANSVERSE PIN, CATALOG #: RD125061, LOT #: 889000; FINN TIBIAL BUSHING, CATALOG #: 153851, LOT #: 361540; FINN FEMORAL BUSHING, CATALOG #: 153852, LOT #: 939970; FINN LOCKING PIN, CATALOG #: 153861, LOT #: 916170; FINN REINFORCED YOKE, CATALOG #: 153865, LOT #: 631720; FINN AXLE, CATALOG #: 153872, LOT #: 940070; FINN MODULAR TIBIAL BEARING, CATALOG #: 153982, LOT #: 852610; FINN MODULAR RESURFACING FEMORAL, CATALOG #: 153802, LOT #: 634170; FINN MODULAR TIBIAL STEM, CATALOG #: 153816, LOT #: 687360; CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-02618; 0001825034-2018-02619; 0001825034-2018-02621; 0001825034-2018-02624; 0001825034-2018-02625; 0001825034-2018-02642; 0001825034-2018-02646; 0001825034-2018-02648; 0001825034-2018-02649; 0001825034-2018-02650; 0001825034-2018-02652; 0001825034-2018-02653; 0001825034-2018-02656; 0001825034-2018-02658; 0001825034-2018-02659.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY THIS REPORT IS A DUPLICATE OF 1825034-2001-00114.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR UNKNOWN REASONS APPROXIMATELY TWO YEARS POST IMPLANTATION . NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271170 COMPRESS ANCHOR PLUG PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. N/A 612530

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R