BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN OXFORD FEMORAL COMPONENT

    MDR report key: 7342215 · Received March 15, 2018

    Report

    Report Number
    3002806535-2018-00443
    Event Type
    Injury
    Date Received
    March 15, 2018
    Report Date
    March 14, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    HRY
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WON SIK CHOY, KWANGWON LEE, HA YONG KIM, KAP JUNG KIM, YOUNG SUB CHUN, DAE SUK YANG, ¿MOBILE BEARING MEDIAL UNICOMPARTMENTAL KNEE ARTHROPLASTY IN PATIENTS WHOSE LIFESTYLES INVOLVE HIGH DEGREES OF KNEE FLEXION: A 10¿14 YEAR FOLLOW-UP STUDY¿.THE KNEE 24 (2017) 829¿836, HTTPS://WWW.NCBI.NLM.NIH.GOV/PUBMED/28571920 MEDICAL PRODUCT - UNKNOWN OXFORD BEARING COMPONENT; UNKNOWN OXFORD TIBIAL COMPONENT REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-201-0442 AND 3002806535-201-0467.

    Description of Event or Problem · 1

    INFORMATION RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE, ENTITLED "MOBILE BEARING MEDIAL UNICOMPARTMENTAL KNEE ARTHROPLASTY IN PATIENTS WHOSE LIFESTYLES INVOLVE HIGH DEGREES OF KNEE FLEXION: A 10-14 YEAR FOLLOW-UP STUDY" ABSTRACT: BACKGROUND: BECAUSE ASIAN POPULATIONS HAVE DIFFERENT LIFESTYLES, SUCH AS SQUATTING AND SITTING ON THE FLOOR, FROM THOSE OF WESTERN POPULATIONS, IT IS POSSIBLE THAT THE CLINICAL RESULTS AND SURVIVAL RATE OF UNICOMPARTMENTAL KNEE ARTHROPLASTY (UKA) FOR ASIAN PATIENTS MAY BE DIFFERENT. THIS STUDY DESCRIBED OUTCOMES OF MOBILE BEARING MEDIAL UKA FOR KOREAN PATIENTS. METHODS: A TOTAL OF THE 164 KNEES TREATED WITH MOBILE BEARING UKAS IN 147 PATIENTS (14 MALES AND 133 FEMALES) WERE REVIEWED. THE MEAN FOLLOW-UP PERIOD WAS 12.1 YEARS (RANGE 10.1¿14). RESULTS: THE CLINICAL OUTCOMES, SUCH AS THE HOSPITAL FOR SPECIAL SURGERY KNEE SCORE, THE OXFORD KNEE SCORE AND THE KNEE SOCIETY RATING SYSTEM, SHOWED STATISTICALLY SIGNIFICANT IMPROVEMENT FROM PRE-OPERATIVE TO FINAL FOLLOW-UP (P B 0.05). A TOTAL OF 26 UKAS (15.8%) REQUIRED REVISION; THE MOST COMMON REASON WAS BEARING DISLOCATION. THE 95% CONFIDENCE INTERVAL OF SURVIVAL RATE AT 12 YEARS WAS 84.1%, WITH REVISION FOR ANY REASON AS THE END POINT. CONCLUSIONS: MINIMALLY INVASIVE MOBILE BEARING UKA IN ASIAN PATIENTS WHO REQUIRED HIGH DEGREES OF KNEE FLEXION SHOWED RAPID RECOVERY AND GOOD CLINICAL OUTCOME. HOWEVER, THEY ALSO SHOWED RELATIVELY HIGH RATES OF BEARING DISLOCATION AND ASEPTIC LOOSENING. THEREFORE, MOBILE BEARING UKA SHOULD ONLY BE PERFORMED IN PATIENTS WHOSE LIFESTYLE INVOLVES HIGH FLEXIONS AFTER CAREFULLY CONSIDERING THESE RISKS AND BENEFITS. THIS COMPLAINT REFERS TO CASE 6 REPORTED IN TABLE 1: CONVERSION TO TOTAL KNEE ARTHROPLASTY DUE TO BEARING DISLOCATION POSTERIORLY VALGUS OVERCORRECTION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187070 UNKNOWN OXFORD FEMORAL COMPONENT HRY BIOMET UK LTD. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R