BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VNGD CR TIB BRG 12X63/67

    MDR report key: 15158603 · Received August 3, 2022

    Report

    Report Number
    0001825034-2022-01780
    Event Type
    Malfunction
    Date Received
    August 3, 2022
    Report Date
    December 1, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K113550
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2022-01786. MEDICAL DEVICES: VANGUARD CR POR FEM-RT 67.5 CATALOG#: 183050 LOT#: 060470 BIOMET POR PRI TIB TRAY 67MM CATALOG#: 141262 LOT#: 349920 BIOMET FINNED PRI STEM 40MM CATALOG#: 141314 LOT#: 164650 TI LOW PROFILE SCREW 6.5X45MM CATALOG#: 103536 LOT: 388660 TI LOW PROFILE SCREW 6.5X25MM CATALOG#: 103532 LOT#: 713120 TI LOW PROFILE SCREW 6.5X35MM CATALOG#: 103534 LOT#: 378430 TI LOW PROFILE SCREW 6.5X35MM CATALOG#: 103534 LOT#: 284720. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: B4, G3, G6, H2, H3, H6, AND H10. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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 · 0

    IT WAS REPORTED PATIENT IS REPORTING KNEE TO BE UNSTABLE APPROXIMATELY 8 MONTHS POST IMPLANTATION. NO REVISION PROCEDURE HAS BEEN REPORTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632187 VNGD CR TIB BRG 12X63/67 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 010970

    Patients

    Seq Age Sex Outcome Treatment
    1 Female