BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REGENEREX PRIMARY PATELLA SERIES A ¿ 3 PEG 34MM

    MDR report key: 6086322 · Received November 8, 2016

    Report

    Report Number
    0001825034-2016-04400
    Event Type
    Injury
    Date Received
    November 8, 2016
    Date of Event
    August 8, 2016
    Report Date
    May 18, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBH
    PMA / PMN Number
    PK083782
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THE LOT RELEASED WITH NO RECORDED ANOMALY. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 9 STATES, ¿FATIGUE FRACTURE OF COMPONENT CAN OCCUR AS A RESULT OF LOSS OF FIXATION, STRENUOUS ACTIVITY, MALALIGNMENT, TRAUMA, NON-UNION, OR EXCESSIVE WEIGHT.¿

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    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. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THE LOT RELEASED WITH NO RECORDED ANOMALY. INVESTIGATION INTO THIS ISSUE IS ONGOING AND WHEN ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED TO THE FDA. CONCOMITANT PRODUCTS: VANGUARD CR FEMORAL RIGHT CATALOG 183044 LOT 844860; BIOMET REGENEREX TIBIAL TRAY CATALOG 141272 LOT 889870; MODULAR SPLINED STEM CATALOG 141369 LOT 431600; E1 VANGUARD AS TIBIAL BEARING CATALOG EP-189042 LOT 915460.

    Description of Event or Problem · 1

    PATIENT UNDERWENT A RIGHT KNEE REVISION PROCEDURE APPROXIMATELY TWO YEARS POST-IMPLANTATION DUE TO THE PATELLA PEGS SHEARING OFF. NO ADDITIONAL INFORMATION IS KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738843 REGENEREX PRIMARY PATELLA SERIES A ¿ 3 PEG 34MM PROSTHESIS, KNEE MBH BIOMET ORTHOPEDICS N/A 101700

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R