BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD(TM) CR FEMORAL 65MM RIGHT - INTERLOK

    MDR report key: 6221678 · Received January 4, 2017

    Report

    Report Number
    0001825034-2017-00024
    Event Type
    Injury
    Date Received
    January 4, 2017
    Date of Event
    December 5, 2016
    Report Date
    April 21, 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
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL PRODUCT - POLISHED FINNED TIB TRAY 75MM# 141254 LOT# 2014060645, VANGUARD CR TIBIAL BEARING CATALOG#183440 LOT # 797130. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. PATIENT DATE OF BIRTH/AGE - NI. PATIENT WEIGHT - NI. EVENT IS BEING REPORTED TO FDA ON THREE MEDWATCHES SINCE THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE OCCURRED. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING THE REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND, IF WARRANTED, FURTHER MEDWATCH REPORTS WILL BE SUBMITTED. THIS REPORT IS NUMBER 1 OF 3 MDRS FILED FOR THE SAME PATIENT (REFERENCE 0009610576-2017-00001 AND 0001825034-2017-00025 ).

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THE REPORTED DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO PAIN AND INSTABILITY CAUSED FROM FALL APPROXIMATELY 14 MONTHS POST IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4376 VANGUARD(TM) CR FEMORAL 65MM RIGHT - INTERLOK PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 321880

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10 NARRATIVE