BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD ANTERIOR STABILIZED TIBIAL BEARING

    MDR report key: 8792803 · Received July 16, 2019

    Report

    Report Number
    0001825034-2019-02990
    Event Type
    Injury
    Date Received
    July 16, 2019
    Date of Event
    January 20, 2016
    Report Date
    November 26, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K113550
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE PRODUCT WAS EVALUATED THROUGH MANUFACTURING REVIEW AND THE REPORTED EVENT WAS CONFIRMED THROUGH REVIEW OF MEDICAL RECORDS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE IDENTIFIED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION 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.

    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: BMET ARCOM AP PAT W/WIRE 31MM CATALOG # 11-150826 LOT # 189710, VANGUARD CR ILOK FEM-LT 67.5 CATALOG # 183030 LOT # 231010, BIOMET CC CRUCIATE TRAY 75MM CATALOG # 141234 LOT # J3465523, COBALT G-HV BONE CEMENT 40G CATALOG # 402283 LOT # 232350, COBALT G-HV BONE CEMENT 40G CATALOG # 402283 LOT # 156410. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. PRODUCT LOCATION IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT A MANIPULATION DUE TO ARTHROFIBROSIS AND LIMITED RANGE OF MOTION ONE MONTH POST OPERATIVE. ADDITIONALLY, THE PATIENT WAS REVISED APPROXIMATELY ONE MONTH LATER DUE TO ARTHROFIBROSIS AND LIMITED RANGE OF MOTION. THE POLYETHYLENE BEARING WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587480 VANGUARD ANTERIOR STABILIZED TIBIAL BEARING PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 781660

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R