BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REGENEREX PRIMARY TIBIAL TRAY

    MDR report key: 6787118 · Received August 10, 2017

    Report

    Report Number
    0001825034-2017-06184
    Event Type
    Injury
    Date Received
    August 10, 2017
    Date of Event
    June 16, 2014
    Report Date
    September 10, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBH
    PMA / PMN Number
    PK080361
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INVESTIGATIVE INPUTS PROVIDED BY THE CUSTOMER. DHR WAS REVIEWED AND NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES WERE IDENTIFIED. 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.

    Additional Manufacturer Narrative · 1

    (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-06183, 0001825034-2017-06185, 0001825034-2017-06186, 0001825034-2017-06187. CONCOMITANT MEDICAL PRODUCTS ¿ RGX 3 PEG SER A PATELLA 34MM CATALOG # 141357, LOT # 305950, E1 VNGD CRL TIB BRG 79/83X10 CATALOG # EP-183560, LOT # 598560, BIOMET FINNED PRI STEM 40MM CATALOG # 141314, LOT # 255870, VANGUARD CR POR FMRL-LT 70 CATALOG # 183072 LOT # 614310, STAGRAFT DBM PUTTY 5CC CATALOG # 92-2003, LOT # 668040. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED,A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN A THE TIME OF THE INITIAL MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT LEFT TOTAL KNEE ARTHROPLASTY AND HAS EXPERIENCED PAIN, IMMEDIATE POST OPERATIVE PRESSURE, LOOSENING, BURNING SENSATION AND SWELLING. A DETERMINATION BY PHYSICIAN AS TO WHETHER THE PATIENT WILL NEED REVISION IS TO FOLLOW. THERE IS NO ADDITIONAL INFORMATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566109 REGENEREX PRIMARY TIBIAL TRAY PROSTHESIS, KNEE MBH BIOMET ORTHOPEDICS N/A 106510

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention