BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN OXFORD FEMORAL COMPONENT

    MDR report key: 7341219 · Received March 15, 2018

    Report

    Report Number
    3002806535-2018-00465
    Event Type
    Injury
    Date Received
    March 15, 2018
    Report Date
    March 15, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ZACHARY C. LUM, DAVID A. CRAWFORD, ADOLPH V. LOMBARDI JR., JASON M. HURST, MICHAEL J. MORRIS B,D, JOANNE B. ADAMS, KEITH R. BEREND: EARLY COMPARATIVE OUTCOMES OF UNICOMPARTMENTAL AND TOTAL KNEE ARTHROPLASTY IN SEVERELY OBESE PATIENTS HTTPS://DOI.ORG/10.1016/J.KNEE.2017.10.006. DEVICE REMAINS IMPLANTED. AS LIMITED INFORMATION WAS RECEIVED FROM THE CUSTOMER, THE REPORTED EVENTS COULD NOT BE CONFIRMED. 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. ZIMMER BIOMET WILL CONTINUE TO MONITOR TRENDS. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    INFORMATION RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE, ENTITLED "EARLY COMPARATIVE OUTCOMES OF UNICOMPARTMENTAL AND TOTAL KNEE ARTHROPLASTY IN SEVERELY OBESE PATIENTS." ABSTRACT: BACKGROUND: MEDIAL UNICOMPARTMENTAL KNEE ARTHROPLASTY (UKA) MAY HAVE ADVANTAGES OVERTOTAL KNEE ARTHROPLASTY (TKA) IN THE SETTING OF OBESITY. THERE HAS BEEN NO DIRECT COMPARISON BETWEEN THE TWO COHORTS. THIS STUDY COMPARES OUTCOMES AND COMPLICATIONS OF SEVERELY OBESE PATIENTS UNDERGOING MEDIAL UKA VERSUS TKA. METHODS: SIX HUNDRED AND FIFTY MEDIAL UKA AND 1300 TKA WERE PERFORMED IN PATIENTS WITH BMI N35 KG/M2 (MEAN 41 KG/M2) BETWEEN 2007 AND 2012. PRE- AND POSTOPERATIVE ROM, KNEE SOCIETY SCORES, PERIOPERATIVE FACTORS, COMPLICATIONS AND REOPERATIONS WERE COMPARED. RESULTS: UKA PATIENTS HAD HIGHER PREOPERATIVE ROM, AND KNEE SOCIETY PAIN (KSP), FUNCTIONAL (KSF), AND CLINICAL (KSC) SCORES (P B 0.001, P = 0.0008, P = 0.0003, P = 0.051 RESPECTIVELY). MEAN TOURNIQUET TIMES, OPERATIVE TIMES, AND LENGTHS OF STAY WERE LOWER AFTER UKA. FOUR TKA PATIENTS REQUIRED TRANSFUSION. MEAN FOLLOW-UP WAS 2.3 YEARS. THE FREQUENCY OF MANIPULATION UNDER ANESTHESIA WAS HIGHER IN TKA PATIENTS (P B 0.001), WHILE THE RATE OF COMPONENT REVISION WAS SIMILAR BETWEEN THE TWO GROUPS (1.2% VS. 1.7%, P = 0.328). FREQUENCY OF DEEP INFECTION WAS LOWER IN THE UKA GROUP (P = 0.016). POSTOPERATIVE KSF, CHANGE IN KSF, AND ROM WERE HIGHER (P B 0.0001) AFTER UKA, BUT KSP AND KSC WERE EQUIVALENT. CONCLUSIONS: SEVERELY OBESE PATIENTS WHO UNDERWENT MEDIAL UKA DEMONSTRATED EQUAL SURVIVORSHIP WITH SUBSTANTIALLY FEWER REOPERATIONS, REDUCED DEEP INFECTION, AND LESS PERIOPERATIVE COMPLICATIONS AT SHORT TERM FOLLOW-UP. SEVERELY OBESE PATIENTS HAD IMPROVED KSF SCORES AND MAINTENANCE OF ROM AFTER UKA COMPARED WITH TKA THIS COMPLAINT REFERS TO REMOVAL OF LOOSE BODY OR CHONDROPLASTY FOLLOWING UKA ARTHROPLASTY PROCEDURES STATED ON PAGE 163.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185896 UNKNOWN OXFORD FEMORAL COMPONENT PROSTHESIS, KNEE JWH BIOMET UK LTD. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R