BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN OXFORD FEMORAL COMPONENT

    MDR report key: 7273241 · Received February 15, 2018

    Report

    Report Number
    3002806535-2018-00320
    Event Type
    Injury
    Date Received
    February 15, 2018
    Report Date
    February 15, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    HRY
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER W. KRISTENSEN, MD, HENRIETTE A. HOLM, RN, CLAUS VARNUM, MD UP TO 10-YEAR FOLLOW-UP OF THE OXFORD MEDIAL PARTIAL KNEE ARTHROPLASTY ¿ 695 CASES FROM A SINGLE INSTITUTION. THE JOURNAL OF ARTHROPLASTY 28 SUPPL. 2 (2013) 195¿198. REPORT SOURCE, FOREIGN - EVENTS OCCURRED IN (B)(6). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER AS THE LOT NUMBERS OF THE DEVICES ARE UNKNOWN, DHR REVIEWS COULD NOT BE PERFORMED. ROOT CAUSE COULD NOT BE DETERMINED. IF FURTHER INFORMATION IS FOUND THAT WOULD CHANGE OR ALTER ANY CONCLUSIONS REACHED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    INFORMATION RECEIVED BASED ON JOURNAL ARTICLE ENTITLED "UP TO 10-YEAR FOLLOW-UP OF THE OXFORD MEDIAL PARTIAL KNEE ARTHROPLASTY ¿ 695 CASES FROM A SINGLE INSTITUTION", BY W. KRISTENSEN, ET AL. (2013). ABSTRACT: PARTIAL KNEE ARTHROPLASTY (PKA) HAS SHOWN OBVIOUS ADVANTAGES COMPARED TO TOTAL KNEE ARTHROPLASTY, BUT SURVIVAL OF PKA FROM DIFFERENT INSTITUTIONS AND REGISTRIES HAS DIFFERED. IN OUR INSTITUTION, 695 CONSECUTIVE OXFORD MEDIAL PKAS WERE PERFORMED FROM 2002 TO 2011 WITH MEAN FOLLOW-UP OF 4.6 YEARS. THE OVERALL 10.7-YEAR SURVIVAL RATE WAS 85.3% (95% CI: 78.7%¿90.0%), AND NO DIFFERENCE IN SURVIVAL FOR GENDER AND AGE YOUNGER OR OLDER THAN 60 YEARS WAS FOUND. ONE YEAR AFTER PKA, 94.3% WERE VERY SATISFIED OR SATISFIED, AS WERE 93.6% SIX YEARS POSTOPERATIVELY. THE REVISION RATE WAS 7.3% (N = 51), AND THE MOST COMMON CAUSES FOR REVISION WERE PROGRESSION OF OSTEOARTHRITIS (N = 16), ASEPTIC LOOSENING (N = 11), AND PAIN WITHOUT LOOSENING (N = 10). ONLY 50% OF PATIENTS REVISED FOR PAIN WITHOUT LOOSENING HAD A SATISFACTORY OUTCOME. THIS COMPLAINTS REFERS TO TWO KNEE REVISIONS DUE TO UNKNOWN REASONS. (PAGE 197, TABLE 2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118504 UNKNOWN OXFORD FEMORAL COMPONENT PROSTHESIS, KNEE HRY BIOMET UK LTD. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R