BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPRESS/FINN TRANSVERSE PIN SIZE 44MM

    MDR report key: 7755185 · Received August 6, 2018

    Report

    Report Number
    0001825034-2018-04666
    Event Type
    Injury
    Date Received
    August 6, 2018
    Date of Event
    March 21, 2005
    Report Date
    August 6, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    PMA / PMN Number
    PK031804
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT DEVICES: FINN SEGMENTAL FEMORAL COMPONENT LEFT, CATALOG #: 153804, LOT #: 259710; ORTHOPEDIC SALVAGE SYSTEM POLYETHYLENE FEMORAL BUSHINGS 2PK, CATALOG #: 150477, LOT #: 242270; ORTHOPEDIC SALVAGE SYSTEM POLYETHYLENE LOCKING PIN, CATALOG #: 150478, LOT #: 545750; ORTHOPEDIC SALVAGE SYSTEM TIBIAL POLYETHYLENE BEARING 12MM, CATALOG #: 150410, LOT #: 130940; ORTHOPEDIC SALVAGE SYSTEM AXLE, CATALOG #: 150480, LOT #: 292200; ORTHOPEDIC SALVAGE SYSTEM POLYETHYLENE TIBIAL BUSHING, CATALOG #: 150476, LOT #: 594690; FINN SEGMENTAL 325MM, CATALOG #: CP112131, LOT #: 751570; COMPRESS NUT, CATALOG #: RD125050, LOT #: 190740; ORTHOPEDIC SALVAGE SYSTEM REINFORCED YOKE, CATALOG #: 150479, LOT #: 551880; CPS SHORT 600LBF SMALL SPINDLE, CATALOG #: CP111164, LOT #: 684980; COMPRESS CUSTOM ANCHOR PLUG 19MM SHORT, CATALOG #: CP111048, LOT #: 685590; COMPRESS/FINN SPACER 25MM, CATALOG #: RD125083, LOT #: 674530. THE COMPLAINANT INDICATED THAT THE REPORTED DEVICE WOULD NOT BE RETURNED TO ZIMMER BIOMET FOR EVALUATION AS THE LOCATION OF THE PRODUCT IS UNKNOWN. THE PRODUCT WAS EVALUATED THROUGH MANUFACTURING REVIEW, HOWEVER, THE REPORTED EVENT COULD NOT BE CONFIRMED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE IDENTIFIED. A 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-02821, 0001825034-2018-04667.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY REVISION TO ADDRESS POST-OPERATIVE IMPLANT LOOSENING. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596290 COMPRESS/FINN TRANSVERSE PIN SIZE 44MM PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. N/A 289030

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization| R