BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPRESS/FINN SPACER

    MDR report key: 7437964 · Received April 17, 2018

    Report

    Report Number
    0001825034-2018-02821
    Event Type
    Injury
    Date Received
    April 17, 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 · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS : 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/FINN TRANSVERSE PIN SIZE 44MM CATALOG #: RD125066 LOT #: 289030, COMPRESS CUSTOM ANCHOR PLUG 19MM SHORT CATALOG #: CP111048 LOT #: 685590 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: 0001825034-2018-04666, 0001825034-2018-04667.

    Additional Manufacturer Narrative · 1

    (B)(4) CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO POST-OPERATIVE LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278530 COMPRESS/FINN SPACER KNEE PROSTHESIS KRO ZIMMER BIOMET, INC. N/A 674530

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization| R