BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODULAR HYBRID GLENOID BASE 4MM

    MDR report key: 6216067 · Received December 30, 2016

    Report

    Report Number
    0001825034-2016-05438
    Event Type
    Injury
    Date Received
    December 30, 2016
    Date of Event
    December 4, 2015
    Report Date
    May 30, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    PK060694
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.THIS REPORT IS NUMBER 3 OF 4 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-05436/ 05437/05438/05441)

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT SHOULDER ARTHROPLASTY. AT SIX (6) WEEK POST-OPERATIVE FOLLOW-UP, PAIN, SUPRASPINATUS/GREATER TUBEROSITY TENDERNESS, BICEPS TENDON TENDERNESS, IMPINGEMENT, AND SUBACROMIAL CREPITUS WERE NOTED. AT THREE (3) MONTH POST-OPERATIVE FOLLOW-UP, CONTINUED PAIN, SUPRASPINATUS/GREATER TUBEROSITY TENDERNESS, AND BICEPS TENDON TENDERNESS WERE NOTED. AT ONE YEAR POST-OPERATIVE FOLLOW-UP, CONTINUED PAIN WAS NOTED. TWO YEAR POST-OPERATIVE FOLLOW-UP NOTED PAIN, INSTABILITY, AND SUBACROMIAL TENDERNESS. APPROXIMATELY TWENTY-FIVE (25) MONTHS POST-OPERATIVELY, POPPING AND CRACKING IN THE OPERATIVE SHOULDER WAS REPORTED. NO REVISION PROCEDURE OR OTHER TREATMENT IS INDICATED AT THIS TIME.

    Description of Event or Problem · 1

    PATIENT UNDERWENT AN INITIAL RIGHT SHOULDER PROCEDURE AND EXPERIENCED A CRACKING/POPPING NOISE AND PAIN 2 YEARS POST OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865954 MODULAR HYBRID GLENOID BASE 4MM PROSTHESIS, SHOULDER KWS BIOMET ORTHOPEDICS NI 985500

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other