BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPRESS CUSTOM ANCHOR PLUG 19MM SHORT

    MDR report key: 7755181 · Received August 6, 2018

    Report

    Report Number
    0001825034-2018-04667
    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
    KWA
    PMA / PMN Number
    PK062998
    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 2 PK CATALOG #: 150477 LOT #: 242270, ORTHOPEDIC SALVAGE SYSTEM POLYETHYLENE LOCKING PIN CATALOG #: 150478 LOT #: 545750, ORTHOPEDIC SALVAGE SYSTEM TIBIAL POLYETHYLENE BEARING 12 MM CATALOG #: 150410 LOT #: 130940, ORTHOPEDIC SALVAGE SYSTEM AXLE CATALOG #: 150480 LOT #: 292200, ORTHOPEDIC SALVAGE SYSTEM POLYETHYLENE TIBIAL BUSHING CATALOG #: 150476 LOT #: 594690, FINN SEGMENTAL 325 MM 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/FINN TRANSVERSE PIN SIZE 44 MM CATALOG #: RD125066 LOT #: 289030, COMPRESS/FINN SPACER 25 MM 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, 0001825034-2018-04666.

    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
    596287 COMPRESS CUSTOM ANCHOR PLUG 19MM SHORT PROSTHESIS, KNEE KWA ZIMMER BIOMET, INC. N/A 685590

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization| R