BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE

    MDR report key: 5095534 · Received September 22, 2015

    Report

    Report Number
    0001825034-2015-04056
    Event Type
    Injury
    Date Received
    September 22, 2015
    Report Date
    September 10, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    NRA
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT CONCLUSIONS AS TO THE CAUSE OF THE EVENTS. EVENT DETAILS AND PRODUCT IDENTIFICATION WAS NOT PROVIDED FOR THE PATIENT MENTIONED IN THE JOURNAL ARTICLE. INITIAL REPORTER - THE ARTICLE WAS WRITTEN BY KENDRICK, B.J.L., ET AL IN J BONE JOINT SURG [BR] 2010; 92-B:367-73. VOL. 92-B, NO. 3, MARCH 2010 DOI: 10.10302/0301-620X.92B3. (B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE TITLED, "POLYETHYLENE WEAR IN OXFORD UNICOMPARTMENTAL KNEE REPLACEMENT: A RETRIEVAL STUDY OF 47 BEARINGS" WHICH CONTAINED A PATIENT WHO UNDERWENT PARTIAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE ON AN UNKNOWN SIDE. SUBSEQUENTLY, PATIENT WAS REVISED ON AN UNKNOWN DATE DUE TO DEEP INFECTION 1.2 YEARS AFTER INITIAL PROCEDURE. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624284 UNKNOWN KNEE PROSTHESIS, KNEE NRA BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R