BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD PS TIBIAL BEARING

    MDR report key: 7786579 · Received August 15, 2018

    Report

    Report Number
    0001825034-2018-04388
    Event Type
    Injury
    Date Received
    August 15, 2018
    Date of Event
    April 10, 2017
    Report Date
    January 25, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HRY
    PMA / PMN Number
    PK171054
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS CONFIRMED BY REVIEW OF OP NOTES WHICH INDICATED VARUS/VALGUS INSTABILITY AND DECREASED EXTENSION WERE NOTED INTRA-OPERATIVELY. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND.ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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 UNDERWENT RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY PATIENT EXPERIENCED PAIN AND SWELLING TWO YEARS AFTER IMPLANTATION. PATIENT SUBSEQUENTLY UNDERWENT A REVISION PROCEDURE FIVE (5) YEARS POST-IMPLANTATION DUE TO PAIN, INSTABILITY, AND LIMITED RANGE OF MOTION IN EXTENSION. A POSTERIOR CAPSULAR RELEASE WAS ALSO PERFORMED TO IMPROVE RANGE OF MOTION. ONLY THE BEARING WAS REVISED AS THE OTHER COMPONENTS WERE NOT DETERMINED TO BE LOOSE.

    Additional Manufacturer Narrative · 1

    (B)(4). UNIQUE IDENTIFIER (UDI) #: N/A. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS PRODUCT HAS BEEN DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. ASSOCIATED PRODUCT: ITEM # 184770, LOT # 079600; ITEM # 183214, LOT # 094410; ITEM # 141228, LOT # J2375563. 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 · 1

    IT WAS REPORTED PATIENT UNDERWENT RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY PATIENT EXPERIENCED PAIN AND SWELLING TWO YEARS AFTER IMPLANTATION. PATIENT UNDERWENT A REVISION LATER DUE TO POSSIBLE LOOSENING. ONLY THE BEARING WAS REVISED AS THE OTHER COMPONENTS WERE NOT DETERMINED TO BE LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625702 VANGUARD PS TIBIAL BEARING PROTHESIS KNEE HRY ZIMMER BIOMET, INC. NI 982480

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R