BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE

    MDR report key: 4929310 · Received July 21, 2015

    Report

    Report Number
    0001825034-2015-03164
    Event Type
    Injury
    Date Received
    July 21, 2015
    Report Date
    June 30, 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
    GM
    Reporter Occupation
    PHYSICIAN

    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. THE ARTICLE WAS WRITTEN BY PIETSCHMANN MF, ET AL IN INT ORTHOP. 2013 JAN;37(1):31-7. DOI: 10.1007/S00264-012-1710-7. 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

    INTERNATIONAL ORTHOPAEDICS (SICOT) (2013) 37:31-37 DOI: 10.1007/S00264-012-1710-7 PIETSCHMANN, M. ET AL. INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE TITLED, "SPORTS ACTIVITIES AFTER MEDIAL UNICOMPARTMENTAL KNEE ARTHROPLASTY OXFORD III - WHAT CAN WE EXPECT?" WHICH AIMED TO EVALUATE THE LONG-TERM RESULTS FOR SPORTS AND PHYSICAL ACTIVITIES OF PATIENTS WHO HAD UNDERGONE IMPLANTATION OF AN OXFORD III MEDIAL UNICOMPARTMENTAL KNEE ARTHROPLASTY (UKA) IN A MINIMALLY INVASIVE TECHNIQUE. THE HYPOTHESIS WAS THAT AFTER OXFORD III UKA IMPLANTATION FOR MEDIAL OSTEOARTHRITIS OF THE KNEE, THERE WOULD BE AN IMPROVEMENT IN SPORTS/PHYSICAL ACTIVITIES. THE OXFORD III UKA IMPLANT WAS MANUFACTURED AT BIOMET. THE STUDY WAS CONDUCTED OVER A PERIOD OF NINE (9) YEARS (1998 TO 2007) AND INVOLVED ONE-HUNDRED SEVENTY-ONE (171) PATIENTS WHO RECEIVED ONE-HUNDRED EIGHTY-ONE (181) KNEES. THE JOURNAL ARTICLE REPORTS THE FOLLOWING REVISIONS BY REASON: FIVE (5) REVISIONS DUE TO OSTEOARTHRITIS ONE (1) REVISION DUE TO LOOSENING ONE (1) REVISION DUE TO INSTABILITY WITH INSERT DISLOCATION ONE (1) REVISION DUE TO DISLOCATION TWO (2) REVISIONS DUE TO IMPINGEMENT ONE (1) REVISION DUE TO INFECTION THE AUTHORS OF THE STUDY CONCLUDE THAT THEY COULD DEMONSTRATE THAT PHYSICALLY ACTIVE PATIENTS WITH AN OXFORD III PROSTHESIS HAVE LESS PAIN AND SHOW HIGHER CLINICAL SCORES. HOWEVER, SINCE THEY COULD NOT FIND SIGNIFICANT DIFFERENCES IN RADIOLOGICAL AND OBJECTIVE SCORES BETWEEN THESE GROUPS, IT REMAINS UNCLEAR IF THIS IS A RESULT OF A ¿SUCCESSFUL¿ IMPLANTATION OR IF THE ACTIVITY ITSELF IS THE REASON FOR THE BETTER OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472194 UNKNOWN KNEE PROSTHESIS, KNEE NRA BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R