BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD UNI FEMORAL SM

    MDR report key: 3013558 · Received March 20, 2013

    Report

    Report Number
    0001825034-2013-00655
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    March 26, 2013
    Report Date
    February 21, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    NRA
    PMA / PMN Number
    PP010014
    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 13 STATES, "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING. MUSCLE AND FIBROUS TISSUE LAXITY CAN ALSO CONTRIBUTE TO THESE CONDITIONS." NUMBER 20 STATES, "PERSISTENT PAIN." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00654 / 00655).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY THE REVISION DATE, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00654-1 / 00655-1).

    Description of Event or Problem · 1

    IT WAS REPORTED BY PATIENT THEY UNDERWENT A PARTIAL KNEE ARTHROPLASTY ON (B)(6) 2011. SUBSEQUENTLY, PATIENT ALLEGES PAIN, SWELLING AND DISLOCATION. THERE HAS BEEN NO REPORTED REVISION PROCEDURE. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY PATIENT THEY UNDERWENT A PARTIAL KNEE ARTHROPLASTY ON (B)(6) 2011. SUBSEQUENTLY, PATIENT WAS ALLEGEDLY REVISED ON (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF PAIN, SWELLING AND DISLOCATION. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116617 OXFORD UNI FEMORAL SM PROSTHESIS, KNEE NRA BIOMET ORTHOPEDICS N/A 2193433

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R