BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF ANAT BRG RT MD SIZE 4 PMA

    MDR report key: 8211688 · Received January 3, 2019

    Report

    Report Number
    3002806535-2019-00008
    Event Type
    Injury
    Date Received
    January 3, 2019
    Date of Event
    December 6, 2018
    Report Date
    June 20, 2019
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    P010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS PROVIDED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT KNEE REPLACEMENT PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE BEARING DISLOCATION. THE PATIENT HAD BEEN WALKING WITH THE DISLOCATION FOR 3 MONTHS. WHEN THE SURGEON OPENED THE KNEE, METALLOSIS WAS PRESENT IN THE SOFT TISSUE.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: OXFORD PH3 CEMENTLESS FEM SZ M, CATALOG #: 154926, LOT #: 6171639, MEDICAL PRODUCT: OXF UNI CMNTLS TIB SZ C RM SIZE 4 PMA, CATALOG #: 166575, LOT #: 6187657. REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2019-00010, 3002806535-2017-00009. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT KNEE REPLACEMENT PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE BEARING DISLOCATION. THE PATIENT HAD BEEN WALKING WITH THE DISLOCATION FOR 3 MONTHS. WHEN THE SURGEON OPENED THE KNEE, METALLOSIS WAS PRESENT IN THE SOFT TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4630 OXF ANAT BRG RT MD SIZE 4 PMA KNEE PROSTHESIS NRA BIOMET UK LTD. N/A 6003906

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R