BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD PKS MEN BEARING UHMWPE MED

    MDR report key: 3820617 · Received May 20, 2014

    Report

    Report Number
    3002806535-2014-00133
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    April 2, 2014
    Report Date
    May 27, 2014
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    PP010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. NO PRODUCT HAS BEEN RETURNED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. EXPIRATION DATE - UNKNOWN; MANUFACTURE DATE - UNKNOWN.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(4) 2014 INCLUDING THE ITEM MANUFACTURE AND EXPIRATION DATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT OXFORD KNEE SURGERY ON (B)(6) 2001. REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2014 DUE TO PAIN AND INSTABILITY. NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300277 OXFORD PKS MEN BEARING UHMWPE MED PROSTHESIS, KNEE NRA BIOMET UK LTD. N/A 379379

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R