BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF ANATOMIC BEARING RT SM SIZE 6

    MDR report key: 3803123 · Received May 9, 2014

    Report

    Report Number
    0001825034-2014-03806
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    July 1, 2014
    Report Date
    March 4, 2016
    Manufacturer
    BIOMET LTD
    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."

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION REGARDING THE DATE OF THE REVISION AND THE EXPIRATION DATE OF THE PRODUCT, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED INFORMATION AND ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    PATIENT REPORTED TO HAVE UNDERGONE RIGHT PARTIAL KNEE ARTHROPLASTY ON (B)(6) 2010. PATIENT ALLEGED THAT RADIOGRAPHS TAKEN ON (B)(6) 2014 REVEALED DISLOCATION OF THE POLYETHYLENE TIBIAL BEARING. THERE HAS BEEN NO REPORTED REVISION TO DATE.

    Description of Event or Problem · 1

    PATIENT REPORTED TO HAVE UNDERGONE RIGHT PARTIAL KNEE ARTHROPLASTY ON (B)(6) 2010. PATIENT ALLEGED THAT RADIOGRAPHS TAKEN ON (B)(6) 2014 REVEALED DISASSOCIATION OF THE POLYETHYLENE TIBIAL BEARING. PATIENT FURTHER REPORTED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2014 IN WHICH THE PARTIAL KNEE COMPONENTS WERE REMOVED AND REPLACED WITH A COMPETITOR TOTAL KNEE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281844 OXF ANATOMIC BEARING RT SM SIZE 6 PROSTHESIS, KNEE NRA BIOMET LTD N/A 404521

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| R