BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEES

    MDR report key: 3081255 · Received April 26, 2013

    Report

    Report Number
    0001825034-2013-01183
    Event Type
    Injury
    Date Received
    April 26, 2013
    Report Date
    April 1, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    NRA
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION BEING REPORTED WAS FOUND IN A JOURNAL ARTICLE TITLED "UNICOMPARTMENTAL KNEE ARTHROPLASTY: INCIDENCE OF TRANSFUSION AND SYMPTOMATIC THROMBOEMBOLIC DISEASE". ORTHOPEDICS (SEPTEMBER 2010) VOLUME 33, ISSUE 9: 8-10. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENTS. EVENT DETAILS AND PRODUCT IDENTIFICATION WAS NOT PROVIDED FOR THE REVISIONS MENTIONED IN ARTICLE WAS WRITTEN BY ADOLPH V. LOMBARDI JR., KEITH R. BEREND AND MICHAEL J. MORRIS. IT IS LIKELY THAT THESE COMPLICATIONS AND REVISIONS HAVE ALREADY BEEN REPORTED; HOWEVER, IT CANNOT BE DETERMINED BASED ON THE LIMITED INFORMATION MADE AVAILABLE IN THE ARTICLE. SHOULD ADDITIONAL INFORMATION RELATING TO THE EVENTS BE RECEIVED, THE UPDATED INFORMATION WILL BE FORWARDED TO THE FDA.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE ON THE OXFORD PHASE III KNEE, VANGUARD M KNEE AND REPICCI II KNEES WHICH FOLLOWED ONE THOUSAND (1000) UNICOMPARTMENTAL KNEE ARTHROPLASTIES IN THE EIGHT HUNDRED TWENTY-EIGHT (828) PATIENTS. NO REVISIONS WERE REPORTED AND A REVIEW OF THEIR SURGICAL RECORDS FOR RATE OF TRANSFUSION, SYMPTOMATIC THROMBOEMBOLIC EVENTS AND LENGTH OF HOSPITAL STAY. PATIENT RECORDS WERE EXAMINED OUT TO 90 DAYS FOR THIS RETROSPECTIVE STUDY. SURGICAL-RELATED COMPLICATIONS ASSOCIATED WITH IMPLANTATION OF OXFORD PHASE III KNEE, VANGUARD M KNEE AND REPICCI II KNEES: FIVE PATIENTS REQUIRED A TRANSFUSION POSTOPERATIVELY FOR SYMPTOMATIC ANEMIA; THREE PATIENTS REQUIRED AN OPERATIVE HEMATOMA EVACUATION; ONE PATIENT DEVELOPED A DOCUMENTED SYMPTOMATIC RVT TREATED WITH LONG-TERM ANTI-COAGULANT THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182897 UNKNOWN KNEES PROSTHESIS, KNEE NRA BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R