BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE

    MDR report key: 4799744 · Received May 27, 2015

    Report

    Report Number
    0001825034-2015-02267
    Event Type
    Injury
    Date Received
    May 27, 2015
    Report Date
    April 29, 2015
    Manufacturer
    BIOMET UK LTD
    Product Code
    NRA
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. DATE OF EVENT - UNKNOWN. EXPIRATION DATE/LOT NUMBER - UNKNOWN. DATE IMPLANTED - UNKNOWN. DATE EXPLANTED - UNKNOWN. INITIAL REPORTER - THE ARTICLE WAS WRITTEN BY H PANDIT IN BONE JOINT SURG (BR} 2011;93-8:198¿204. PMA/510(K) NUMBER ¿ UNKNOWN. MANUFACTURE DATE ¿ UNKNOWN. THIS INFORMATION WAS ORIGINALLY REPORTED ON 1825034-2015-02246 WHICH REFERENCED A JOURNAL ARTICLE WRITTEN ON A STUDY THAT THIS PATIENT TOOK PART IN.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE ENTITLED, "MINIMALLY INVASIVE OXFORD PHASE 3 UNICOMPARTMENTAL KNEE REPLACEMENT." THIS PROSPECTIVE STUDY DESCRIBES THE OUTCOME OF THE FIRST 1000 PHASE 3 OXFORD MEDIAL UNICOMPARTMENTAL KNEE REPLACEMENTS IMPLANTED USING A MINIMALLY INVASIVE SURGICAL APPROACH FOR THE RECOMMENDED INDICATIONS BY TWO SURGEONS AND FOLLOWED UP INDEPENDENTLY. A PATIENT WAS IDENTIFIED IN THE ARTICLE THAT UNDERWENT PARTIAL KNEE ARTHROPLASTY ON AN UNKNOWN SIDE ON AN UNKNOWN DATE. PATIENT FOLLOW-UP RESULTS PROVIDED AT 8.97 YEAR POST-IMPLANTATION INDICATES PATIENT UNDERWENT A REVISION SURGERY ON AN UNKNOWN DATE DUE TO PAIN. THERE HAS BEEN NO FURTHER INFORMATION PROVIDED AND THE PATIENT OUTCOME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343027 UNKNOWN KNEE PROSTHESIS, KNEE NRA BIOMET UK LTD N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R