BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGC MODULAR POST SCREW

    MDR report key: 8394216 · Received March 6, 2019

    Report

    Report Number
    0001825034-2019-01017
    Event Type
    Malfunction
    Date Received
    March 6, 2019
    Date of Event
    July 9, 2018
    Report Date
    July 16, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K171054
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE WAS NOT RETURNED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: VANGUARD (TM) SSK FEMORAL CATALOG # 183300 LOT # 460060. BIOMET OFFSET TIBIAL TRAY ADAPTOR CATALOG # 141490 LOT # 207560. RHK CEMENTED STEM CATALOG # 159403 LOT # UNKNOWN. RHK CEMENTED STEM CATALOG # 159405 LOT UNKNOWN. BIOMET OFFSET TIBIAL TRAY 67MM CATALOG # 141482 LOT # 985260. VNGD SSKPSC TIB BRG S 16X63/67 CATALOG # 183826 LOT # 467180. SERIES A PAT STD 31 3 PEG CATALOG # 184764 LOT 494690. REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE IT WAS DISCARDED BY HOSPITAL. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILLED FOR THIS EVENT: 0001825034-2019-01022, 0001825034-2019-01023, 0001825034-2019-01024.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DURING REVISION PROCEDURE THE TIBIAL PROSTHESIS WAS REMOVED FROM THE PATIENT AFTER SEVERAL ATTEMPTS. THE FEMORAL AND DISTAL TIBIAL COMPONENTS WERE UNABLE TO BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189688 AGC MODULAR POST SCREW PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 570770

    Patients

    Seq Age Sex Outcome Treatment
    1