BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF ANATOMIC BRG RT MD SIZE 4

    MDR report key: 3802249 · Received May 9, 2014

    Report

    Report Number
    0001825034-2014-03782
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 30, 2014
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY REVISION PROCEDURE DATE, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    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.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A PARTIAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE. A REVISION PROCEDURE HAS BEEN INDICATED WHERE SURGEON WILL ADDRESS A FEMORAL FRACTURE AND IMPLANT A LARGER TIBIAL BEARING; HOWEVER, THERE HAS BEEN NO REPORTED PROCEDURE TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT PARTIAL KNEE ARTHROPLASTY ON (B)(6) 2014. A REVISION PROCEDURE HAS BEEN INDICATED DUE TO A TIBIA FRACTURE CAUSING THE TIBIAL TRAY TO SUBSIDE AND THE TIBIAL BEARING TO LOOSEN; HOWEVER, THERE HAS BEEN NO REPORTED PROCEDURE TO DATE. IT WAS FURTHER NOTED THE FRACTURE WAS A STRESS FRACTURE AND NOT IMPLANT RELATED. ADDITIONAL INFORMATION RECEIVED NOTED PATIENT WAS REVISED ON (B)(6) 2014. THE TIBIAL BEARING WAS REMOVED AND REPLACED AND A BUTTRESS PLATE WAS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT PARTIAL KNEE ARTHROPLASTY ON (B)(6) 2014. A REVISION PROCEDURE HAS BEEN INDICATED DUE TO A TIBIA FRACTURE CAUSING THE TIBIAL TRAY TO SUBSIDE AND THE TIBIAL BEARING TO LOOSEN; HOWEVER, THERE HAS BEEN NO REPORTED PROCEDURE TO DATE. IT WAS FURTHER NOTED THE FRACTURE WAS A STRESS FRACTURE AND NOT IMPLANT RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280594 OXF ANATOMIC BRG RT MD SIZE 4 PROSTHESIS, KNEE NRA BIOMET ORTHOPEDICS N/A 3036642

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R