BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNGD PS TIB BRG 10X63/67MM

    MDR report key: 6301695 · Received February 3, 2017

    Report

    Report Number
    0001825034-2017-00382
    Event Type
    Injury
    Date Received
    February 3, 2017
    Date of Event
    September 23, 2016
    Report Date
    March 22, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK023546
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO CORRECT INFORMATION AND RELAY ADDITIONAL INFORMATION. NO DEVICES WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. REVIEW OF DEVICE HISTORY RECORDS FOUND THESE UNITS WERE RELEASED TO DISTRIBUTOR WITH NO DEVIATIONS OR ABNORMALITIES. THE FOLLOWING COMPONENTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED: 183620, 141251, AND 183124. REVIEW OF THE COMPLAINT HISTORIES IDENTIFIED ADDITIONAL COMPLAINTS THAT WERE INVESTIGATED, AND IT WAS DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS PAIN IS SUBJECTIVE. ADDITIONALLY, NO FURTHER ACTION IS REQUIRED FOR LIMITED RANGE OF MOTION DUE TO THE TIME FRAME OVER WHICH THE PRODUCTS WERE MANUFACTURED WITH SIMILAR ISSUES. ROOT CAUSE COULD NOT BE DETERMINED WITH INFORMATION AVAILABLE. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. 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.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. FINNED TIBIAL TRAY CATALOG 141251 LOT 2013010375; VANGUARD PS FEMORAL CATALOG 183124 LOT 961460.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE REVISION APPROXIMATELY SIX MONTHS POST IMPLANTATION DUE TO PAIN, DIFFICULTY MOBILIZING, AND THE FORMATION OF AN UNKNOWN DARK SPOT NEAR THE PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84455 VNGD PS TIB BRG 10X63/67MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 116140

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization