BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PT HYBRID GLENOID POST REGENEREX POROUS TITANIUM CONSTRUCT

    MDR report key: 6136578 · Received November 30, 2016

    Report

    Report Number
    0001825034-2016-04926
    Event Type
    Injury
    Date Received
    November 30, 2016
    Report Date
    April 24, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    PK060694
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RECEIVED FOR EVALUATION, HOWEVER DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. INVESTIGATION RESULTS CONCLUDED THAT THE SNAPPING/POPPING AND INCREASED PAIN THAT OCCURRED ONE YEAR POST OP IS DUE TO PATIENT ACCIDENT/INJURY. FOR ALL OTHER COMPLICATIONS, THE ROOT CAUSE IS UNABLE TO BE DETERMINED. 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 4 OF 4 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-04922 / 04923 / 04924).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT TOTAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN, INSTABILITY, SUPRASPINATUS/GREATER TUBEROSITY TENDERNESS, AND BICEPS TENDON TENDERNESS NOTED AT SIX (6) WEEK POST-OPERATIVE FOLLOW-UP. CONTINUED PAIN, INSTABILITY, SUPRASPINATUS/GREATER TUBEROSITY TENDERNESS, ACROMIOCLAVICULAR JOINT TENDERNESS, AND IMPINGEMENT WERE NOTED AT THREE (3) MONTH POST-OPERATIVE FOLLOW-UP. LASTLY, INSTABILITY, ACROMIOCLAVICULAR JOINT TENDERNESS, BICEPS TENDON TENDERNESS, AND INCREASING PAIN WERE NOTED APPROXIMATELY ONE (1) YEAR POST-OPERATIVELY. THE CONDITION IS NOTED TO BE TOLERATED AT THIS TIME, WITH NO REVISION INDICATED TO DATE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT IS EXPERIENCING INCREASING PAIN, INSTABILITY, AND POPPING SOUNDS FOLLOWING RIGHT SHOULDER ARTHROPLASTY ONE YEAR POST-OPERATIVELY. IMPINGEMENT WAS ALSO NOTED AT 3 MONTH FOLLOW-UP POST-OPERATIVELY, BUT HAS SINCE BEEN REPORTED TO HAVE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785431 PT HYBRID GLENOID POST REGENEREX POROUS TITANIUM CONSTRUCT PROSTHESIS, SHOULDER KWS BIOMET ORTHOPEDICS NA 000590

    Patients

    Seq Age Sex Outcome Treatment
    1 Other