BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN REPICCI II KNEE

    MDR report key: 3081238 · Received April 26, 2013

    Report

    Report Number
    0001825034-2013-01182
    Event Type
    Injury
    Date Received
    April 26, 2013
    Report Date
    April 1, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HRY
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION BEING REPORTED WAS FOUND IN A JOURNAL ARTICLE TITLED "REVISION OF MINIMAL RESECTION RESURFACING UNICONDYLAR KNEE ARTHROPLASTY TO TOTAL KNEE ARTHROPLASTY". J ARTHROPLASTY. 2013 JAN; 28(1): 33-39. 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 THE ARTICLE WAS WRITTEN BY TURLOUGH M.P. O'DONNELL, OMAR ABOUAZZA, AND MICHAEL J. NEIL. 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 WHICH COMPARED PATIENTS UNDERGOING A REVISION OF UNICONDYLAR KNEE ARTHROPLASTY TO TOTAL KNEE ARTHROPLASTY TO PATIENTS UNDERGOING A PRIMARY TOTAL KNEE ARTHROPLASTY. THERE WERE FIFTY-FIVE (55) WHO UNDERWENT A REVISION FROM 2003 TO 2008 FROM THE UNICONDYLAR KNEE ARTHROPLASTY TO THE TOTAL KNEE ARTHROPLASTY. THE ARTICLE REPORTED THE FOLLOWING REVISIONS FOR THE UNICONDYLAR KNEE ARTHROPLASTY FORTY-TWO (42) REVISIONS OF THE REPICCI II KNEES AND THIRTEEN (13) FROM A COMPETITOR MANUFACTURER. REASONS FOR REVISIONS INCLUDED THE FOLLOWING (REVISIONS WERE NOT ASSOCIATED WITH SPECIFIC BRANDS): THIRTY-TWO REVISIONS DUE TO BASEPLATE SUBSIDENCE; TWELVE REVISIONS DUE TO PROGRESSION OF DISEASE TO OTHER COMPARTMENTS; FIVE REVISIONS DUE TO STRESS FRACTURE OF THE TIBIA; FOUR REVISIONS DUE TO ASEPTIC LOOSENING; ONE REVISION DUE TO AVASCULAR NECROSIS OF THE FEMORAL CONDYLE; ONE REVISION DUE TO EXCESSIVE CEMENT DEBRIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182434 UNKNOWN REPICCI II KNEE PROSTHESIS, KNEE HRY BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R