BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMUR TRABECULAR METAL CRUCIATE RETAINING (CR) NARROW POROUS

    MDR report key: 8531441 · Received April 19, 2019

    Report

    Report Number
    0001822565-2019-01624
    Event Type
    Injury
    Date Received
    April 19, 2019
    Date of Event
    August 12, 2015
    Report Date
    April 19, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBH
    PMA / PMN Number
    K121771
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT; PLEASE SEE ASSOCIATED REPORTS: 0001822565-2019-01626, 0001822565-2016-03103-1. EVALUATION OF THE RETURNED TIBIAL COMPONENT IDENTIFIED BONE CEMENT IN THE TM MATERIAL. BOTH OF THE TM PEGS HAD BEEN CUT OFF. THE FEMORAL COMPONENT HAD BONE CEMENT IN THE TM AND SURFACE BLEMISHES (NICKS, SCRATCHES) ON THE CONDYLES AND ANTERIOR FLANGE. THE ARTICULAR SURFACE HAD NICKS AND GOUGES ON THE PROXIMAL FACE AND DAMAGE TO THE DOVETAIL THAT APPEARED TO BE FROM REMOVAL OF THE DEVICE. ASSESSMENT OF X-RAYS IDENTIFIED THE FEMORAL COMPONENT SAGITTAL ALIGNMENT IS APPROXIMATELY 2 DEGREE FLEXION AND THAT THE ANTERIOR FLANGE IS NOT FLUSH WITH THE VENTRAL CORTEX OF THE FEMUR, WHICH CAN BE A SOURCE OF KNEE PAIN. THE REVIEW ALSO NOTED THE TIBIAL COMPONENT CORONAL ALIGNMENT WAS 6 DEGREES VARUS AND MEDIAL OVERHANG OF THE TIBIAL TRAY WAS PRESENT, WHICH CAN BE A SOURCE OF KNEE PAIN. REVIEW OF THE REVISION SURGERY NOTES IDENTIFIED THE COMPONENT ALIGNMENT WAS NOT DESCRIBED OR LISTED AS AN INDICATION FOR REVISION. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. PER THE PERSONA KNEE SYSTEM PACKAGE INSERT PAIN IS A KNOWN POTENTIAL ADVERSE EFFECT OF THIS PROCEDURE. THE UPDATED INFORMATION DOES NOT CHANGE THE PREVIOUS INVESTIGATION CONCLUSIONS. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. 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 PATIENT UNDERWENT REVISION SURGERY DUE TO PAIN APPROXIMATELY 1 YEAR POST INITIAL IMPLANTATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324978 FEMUR TRABECULAR METAL CRUCIATE RETAINING (CR) NARROW POROUS PROSTHESIS, KNEE MBH ZIMMER BIOMET, INC. N/A 62789579

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R