BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E1 VNGD PS TIB BRG 71/75X12

    MDR report key: 5331812 · Received December 29, 2015

    Report

    Report Number
    0001825034-2015-05178
    Event Type
    Injury
    Date Received
    December 29, 2015
    Date of Event
    November 20, 2014
    Report Date
    January 11, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK080528
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 4 STATES, ¿LOOSENING OR MIGRATION OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION OR EXCESSIVE ACTIVITY.¿ THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 1 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2015-05178 / 05179 / 05180).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THIS REPORT IS NUMBER 1 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2015-05178-1 / 2015-05179-1 / 2015-05180-1 / 2016-00295).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2014. PATIENT EXPERIENCED A QUAD MUSCLE TEAR EIGHT WEEKS POST OP; HOWEVER, THE EVENT WAS NOT RELATED TO IMPLANTS. PATIENT UNDERWENT A PROCEDURE TO REPAIR THE TEAR. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2014 DUE TO INSTABILITY. THE BEARING WAS REMOVED AND REPLACED. PATIENT REPORTS EXPERIENCING PAIN AND DRAINING FLUID. IT IS FURTHER REPORTED THAT PATIENT MAY HAVE A METAL ALLERGY. NO FURTHER INFORMATION HAS BEEN PROVIDED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2014. PATIENT EXPERIENCED A QUAD MUSCLE TEAR EIGHT WEEKS POST OP; HOWEVER, THE EVENT WAS NOT RELATED TO IMPLANTS. PATIENT UNDERWENT A PROCEDURE TO REPAIR THE TEAR. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2014 DUE TO INSTABILITY. THE BEARING WAS REMOVED AND REPLACED. PATIENT REPORTS EXPERIENCING PAIN AND DRAINING FLUID. NO FURTHER INFORMATION HAS BEEN PROVIDED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT铠COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855882 E1 VNGD PS TIB BRG 71/75X12 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 010430

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R