BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET REGENENEREX PRIMARY TIBIAL TRAY WITH LOCKING BAR

    MDR report key: 6297840 · Received February 2, 2017

    Report

    Report Number
    0001825034-2017-00410
    Event Type
    Injury
    Date Received
    February 2, 2017
    Date of Event
    October 18, 2016
    Report Date
    May 18, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBH
    PMA / PMN Number
    PK080361
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED: DATE OF BIRTH-NI. WEIGHT-NI. UDI - (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM141314, BIOMET FINNED PRI STEM 40 MM WITH SCREW, LOT 082960. ITEM184768, VANGUARD SERIES A STANDARD PATELLA, LOT 772770. ITEM EP-183460, VANGUARD CR TIBIAL BEARING, LOT 571090. ITEM 183012, VANGUARD (TM) CR INTERLOK FEMORAL-RT, LOT 909410. THIS REPORT IS NUMBER 2 OF 5 MDRS FILED FOR THE SAME PATIENT (REFERENCE 0001825034-2017-00409/0001825034-2017-0040/0001825034-2017-00411/0001825034-2017-00410/0001825034-2017-00412).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THE REVIEW OF DEVICE HISTORY RECORDS DISCOVERED NO DEVIATIONS OR ABNORMALITIES THAT ARE RELATED TO THIS EVENT. THE FOLLOWING COMPONENTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. THESE DEVICES ARE USED FOR TREATMENT. ROOT CAUSE COULD NOT BE DETERMINED WITH INFORMATION AVAILABLE. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION PROCEDURE DUE TO PAIN AND LACK OF MOTION APPROXIMATELY SIXTEEN (16) MONTHS POST IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80354 BIOMET REGENENEREX PRIMARY TIBIAL TRAY WITH LOCKING BAR PROSTHESIS, KNEE MBH BIOMET ORTHOPEDICS N/A 090580

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R