BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAX PRI DCM TIB BRNG12X71/75MM

    MDR report key: 7515189 · Received May 15, 2018

    Report

    Report Number
    0001825034-2018-03348
    Event Type
    Injury
    Date Received
    May 15, 2018
    Report Date
    October 10, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK915132
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION PROVIDED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO ANOMOLIES FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 141314, BIOMET FINNED PRI STEM 40MM, 333260, 140052, MAXIM POR ANA PRI FML 65 RT, 230920, 11-150852, BMET ARCOM POR 4SPIKE PAT 31MM, 141410, 141263, BIOMET POR PRI TIB TRAY 71MM, 139040, 103532, TI LOW PROFILE SCREW 6.5X25MM, 120650, 103535, TI LOW PROFILE SCREW 6.5X40MM, 291200. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT A MANIPULATION PROCEDURE DUE TO PAIN AND INABILITY TO BEND THE KNEE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356798 MAX PRI DCM TIB BRNG12X71/75MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 245650

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R