BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BCM PALACOS UNKNOWN

    MDR report key: 7262200 · Received February 9, 2018

    Report

    Report Number
    0001822565-2018-00603
    Event Type
    Injury
    Date Received
    February 9, 2018
    Date of Event
    March 6, 2014
    Report Date
    September 14, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOREIGN: (B)(6). CONCOMITANT MEDICAL PRODUCTS: BIOMET TIBIAL TRAY WITH LOCKING BAR AND SCREW CAT#: 185203, LOT#: 736840, BIOMET SPLINED KNEE STEM CAT#: 141616, LOT#: 640150, VNGD PS+ TIB BRG 14X59MM CAT#: 183704, LOT#: UNK, VNGD PS TIB BRG 14X71/75MM CAT#: 183644, LOT#: UNK. 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 - 00522, 0001825034 - 2018 - 00523, 0001822565 - 2018 - 00603. PRODUCT LOCATION IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MEDICAL PRODUCTS - UNKNOWN STEM CATALOG #: UNKNOWN LOT #: UNKNOWN BIOMET TIBIAL TRAY WITH LOCKING BAR AND SCREW CATALOG #: 185203 LOT #: 736840 UNKNOWN VANGUARD 360 BEARING CATALOG #: UNKNOWN LOT #: UNKNOWN UNKNON VANGUARD 360 FEMORAL CATALOG #: UNKNOWN LOT #: UNKNOWN BIOMET SPLINED KNEE STEM CATALOG #: 141616 LOT #: 640150 REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED TWO YEARS AFTER INITIAL RIGHT KNEE PROCEDURE DUE TO TIBIAL BASE PLATE LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103103 BCM PALACOS UNKNOWN PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R