BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYBRID GLENOID BASE, 4 MM SMALL

    MDR report key: 6521624 · Received April 26, 2017

    Report

    Report Number
    0001825034-2017-02780
    Event Type
    Malfunction
    Date Received
    April 26, 2017
    Date of Event
    January 15, 2016
    Report Date
    April 26, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    PK060694
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT REMAINS IMPLANTED. CONCOMITANT MEDICAL PRODUCT: HYBRID GLENOID POROUS TITANIUM GLENOID POST, CAT#: PT-113950, LOT#: 220380; VERSA-DIAL 46X21X50 HUMERAL HEAD, CAT#: 113044, LOT#: 395280; VERSA-DIAL/COMPREHENSIVE TI STANDARD TAPER, CAT#: 118001, LOT#: 780550; COMPREHENSIVE NANO HUMERAL PPS, CAT#: US-115734, LOT#:402820. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 825034-2017-02780, 02782. 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.

    Description of Event or Problem · 1

    IT IS REPORTED THAT GLENOID RADIOLUCENCY WAS NOTED APPROXIMATELY ONE MONTH POST-OPERATIVELY OF A LEFT SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THREE MONTH FOLLOW-UP NOTED THAT THE RADIOLUCENCY IS PROGRESSIVE. NO REVISION SURGERY HAS BEEN INDICATED OR REPORTED TO DATE, AS THE CONDITION IS TOLERATED. PATIENT ALSO REPORTED PAIN AND IMPINGEMENT AT THE 6-WEEK FOLLOW-UP, HOWEVER THIS WAS REPORTED TO HAVE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305965 HYBRID GLENOID BASE, 4 MM SMALL PROSTHESIS, SHOULDER KWS BIOMET ORTHOPEDICS N/A 810330

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR