BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET COMPREHENSIVE TOTAL SHOULDER REPLACEMENT

    MDR report key: 7104411 · Received December 8, 2017

    Report

    Report Number
    MW5073872
    Event Type
    Injury
    Date Received
    December 8, 2017
    Date of Event
    March 19, 2015
    Report Date
    December 4, 2017
    Manufacturer
    BIOMET
    Product Code
    KWS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFTER A LONG HISTORY OF SHOULDER PAIN (DUE TO LEFT SHOULDER OSTEOARTHRITIS AND BICEPS TENDONITIS) AND FAILURE OF CONSERVATIVE TREATMENT, I HAD A LEFT TOTAL SHOULDER ARTHROPLASTY ON (B)(6) 2015. THIS ARTHROPLASTY FAILED, SO I UNDERWENT A REVISION TO THE REVERSE SHOULDER ARTHROPLASTY ON (B)(6) 2016. BIOMET CEMENT BNE COBALT G-HV 40/20GM: ITEM SERIAL NUMBER: (B)(4), LRB NUMBER: 58840; LOT NUMBER: 674560; BIOMET PT HYBRID GLENOID POST: LOT NUMBER: 557860; BIOMET BASEPLT GLEN HYBRID SM 4MM: (B)(4), LRB NUMBER: 105323; LOT NUMBER: 531560; BIOMET ARTHREX SUTURE BUTTON 12MM: LOT NUMBER: 1192105; BIOMET HEAD HUM VERSA-DIAL STD TAPR: ITEM SERIAL NUMBER: (B)(4), LRB NUMBER: 92096; LOT NUMBER: 901490; COMPREHENSIVE BIOMET STEM HUM PRI MINI 12MM: ITEM SERIAL NUMBER: (B)(4), LRB NUMBER: 91075; LOT NUMBER: 703850; BIOMET VERSA-DIAL HEAD HUM BPLR 42X18X46MM: ITEM SERIAL NUMBER: (B)(4), LRB NUMBER: 100455; LOT NUMBER: 765380.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    881532 BIOMET COMPREHENSIVE TOTAL SHOULDER REPLACEMENT BIOMET COMPREHENSIVE TOTAL SHOULDER REPLACEMENT KWS BIOMET
    881533 BIOMET COMPREHENSIVE TOTAL SHOULDER REPLACEMENT BIOMET COMPREHENSIVE TOTAL SHOULDER REPLACEMENT KWS BIOMET

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R| S