BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN OXFORD PHASE III BEARING

    MDR report key: 7352384 · Received March 20, 2018

    Report

    Report Number
    3002806535-2018-00519
    Event Type
    Injury
    Date Received
    March 20, 2018
    Report Date
    March 20, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JWH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SUPERIOR FEMORAL COMPONENT ALIGNMENT CAN BE ACHIEVED WITH OXFORD MICROPLASTY INSTRUMENTATION AFTER MINIMALLY INVASIVE UNICOMPARTMENTAL KNEE ARTHROPLASTY YIHUI TU, HUAMING XUE, TONG MA, TAO WEN, TAO YANG, HUI ZHANG1, MINWEI CAI KNEE SURG SPORTS TRAUMATOL ARTHROSC (2017) 25:729¿735. (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. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    INFORMATION RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE, ENTITLED SUPERIOR FEMORAL COMPONENT ALIGNMENT CAN BE ACHIEVED WITH OXFORD MICROPLASTY INSTRUMENTATION AFTER MINIMALLY INVASIVE UNICOMPARTMENTAL KNEE ARTHROPLASTY. AUTHORS: YIHUI TU · HUAMING XUE · TONG MA · TAO WEN · TAO YANG · HUI ZHANG · MINWEI CAI ABSTRACT: PURPOSE OXFORD MICROPLASTY (MP) INSTRUMENTATION HAS BEEN DEVELOPED TO FACILITATE THE REPRODUCIBLE AND CONSISTENT PERFORMANCE OF MINIMALLY INVASIVE UNICOMPARTMENTAL KNEE ARTHROPLASTY (MI-UKA) OPERATION. THE AIM OF THIS STUDY WAS TO COMPARE THE CLINICAL AND RADIOGRAPHIC RESULTS OF TWO GROUPS OF PATIENTS IMPLANTED USING EITHER A CONVENTIONAL INSTRUMENTATION TECHNIQUE OR AN MP TECHNIQUE. METHODS A PROSPECTIVE COHORT STUDY OF 108 KNEES IN 108 PATIENTS WHO UNDERWENT AN MI-UKA PROCEDURE USING EITHER CONVENTIONALLY INSTRUMENTED UKA (CI-UKA) (52 KNEES OF 52 PATIENTS) OR MP-ASSISTED UKA (MP-UKA) (56 KNEES OF 56 PATIENTS). THE CLINICAL ASSESSMENT INCLUDED THE OXFORD KNEE SCORE (OKS), THE KNEE SOCIETY SCORE (KSS), A VISUAL ANALOGUE SCALE (VAS) FOR PAIN, AND RANGE OF MOTION (ROM). COMPLICATIONS WERE ALSO RECORDED. RESULTS NO SIGNIFICANT DIFFERENCES WERE OBSERVED BETWEEN THE TWO GROUPS REGARDING OKS, KSS, VAS, AND ROM. THERE WERE ALSO NO SIGNIFICANT DIFFERENCES IN TERMS OF MECHANICAL LIMB ALIGNMENT AND TIBIA IMPLANT ALIGNMENT. HOWEVER, THE MP-UKA GROUP SHOWED SIGNIFICANTLY MORE ACCURATE POSITIONING OF THE FEMORAL COMPONENT THAN THE CIUKA GROUP. ADDITIONALLY, THE MP-UKA GROUP HAD MORE FEMORAL PROSTHESES IMPLANTED IN THE ¿SATISFACTORY¿ RANGE AND FEWER ¿OUTLIERS¿ THAN THE CI-UKA GROUP. NO SIGNIFICANT DIFFERENCE IN COMPLICATIONS WAS NOTED BETWEEN THE TWO GROUPS. THIS COMPLAINT REFERS TO 1 CASE OF MOBILE BEARING DISLOCATION MENTIONED IN THE CLINICAL OUTCOME SECTION ON PAGE 732.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199191 UNKNOWN OXFORD PHASE III BEARING PROSTHESIS, KNEE JWH BIOMET UK LTD. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention