BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 4812127 · Received June 2, 2015

    Report

    Report Number
    0001825034-2015-02283
    Event Type
    Injury
    Date Received
    June 2, 2015
    Report Date
    April 29, 2015
    Manufacturer
    BIOMET ORTHOPEDICS UK
    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 PATIENTS MENTIONED IN THE JOURNAL ARTICLE. INITIAL REPORTER - THE ARTICLE WAS WRITTEN BY J.S WESTON-SIMONS IN THE BONE AND JOINT JOURNAL (2014): 96-B:59-64. THIS INFORMATION WAS ORIGINALLY REPORTED ON 1825034-2015-02228 WHICH REFERENCED A JOURNAL ARTICLE WRITTEN ON A STUDY THAT THIS PATIENT TOOK PART IN. (B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE TITLED, "THE MID-TERM OUTCOMES OF THE OXFORD DOMED LATERAL UNICOMPARTMENTAL KNEE REPLACEMENT" WHICH AIMED TO ASSESS THE SURVIVAL AND CLINICAL OUTCOMES OF THE DOMED OXFORD UNICOMPARTIMENTAL KNEE REPLACEMENT IN A LARGE PATIENT COHORT IN THE MEDIUM TERM USING THE OXFORD UNICOMPARTIMENTAL KNEE REVISION, MANUFACTURED AT BIOMET. A PATIENT WAS IDENTIFIED IN THE ARTICLE THAT UNDERWENT PARTIAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, PATIENT UNDERWENT REVISION ON AN UNKNOWN DATE DUE TO PAIN 34 MONTHS AFTER INITIAL PROCEDURE. THERE HAS BEEN NO FURTHER INFORMATION PROVIDED AND THE PATIENT OUTCOME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356616 UNKNOWN PROTHESIS KNEE NRA BIOMET ORTHOPEDICS UK N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R