BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPR NANO HMRL PPS 32MM

    MDR report key: 8996567 · Received September 11, 2019

    Report

    Report Number
    0001825034-2019-04047
    Event Type
    Injury
    Date Received
    September 11, 2019
    Date of Event
    July 3, 2018
    Report Date
    September 11, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBF
    PMA / PMN Number
    K060716
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 113952,MODULAR HYBRID GLENOID BASE, 932710, PT-113950,MODULAR HYBRID GLENOID POST¿REGENEREX, 573810, 113032,VERSA-DIAL HUMERAL HEAD, 842820, 118001,VERSA-DIAL/COMP TI STD TAPER, 076840. REPORT SOURCE: (B)(6). COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. AS PER THE OPERATIVE RECORDS AND X-RAYS PROVIDED, THE ROTATOR CUFF WAS NORMAL. HUMERAL HEAD HAD NORMAL CONTOUR AND THE GLENOID WAS NORMAL. THERE WERE NO COMPLICATIONS, DEVIATIONS FROM SURGICAL TECHNIQUE, OR DELAYS IN THE PROCEDURE. AS PER THE X-RAY REVIEW OF 6-MONTHS POST INITIAL SURGERY, NO GLENOID AND HUMERAL RADIOLUCENCY, SUBSIDENCE, OSTEOLYSIS, MIGRATION, INTEGRITY IS INTACT AND NO BONE FRACTURE. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2019 - 02386, 0001825034 - 2019 - 02388, 0001825034 - 2019 - 02389, 0001825034 - 2019 - 02385.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT PATIENT HAD INITIAL COMPREHENSIVE SHOULDER ARTHROPLASTY. SUBSEQUENTLY, PATIENT SUFFERED SHOULDER PAIN, INSTABILITY, TENDERNESS, DECREASE IN ADLS AND IMPINGEMENT. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791986 COMPR NANO HMRL PPS 32MM PROSTHESIS, SHOULDER MBF ZIMMER BIOMET, INC. N/A 410710

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R