BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVRS 25MM BSPLT HA+ADPTR

    MDR report key: 7414666 · Received April 10, 2018

    Report

    Report Number
    0001825034-2018-02449
    Event Type
    Injury
    Date Received
    April 10, 2018
    Date of Event
    September 21, 2015
    Report Date
    June 5, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    PK120121
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF OPERATIVE NOTES. 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. 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: 0001825034-2018-02448, 0001825034-2018-03159, 0001825034 - 2018 - 03160, 0001825034 - 2018 - 03161.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE PATIENT¿S LEGAL COUNSEL THAT THE PATIENT UNDERWENT RIGHT SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO A CENTRAL SCREW FRACTURE AND A LOOSE, DISASSOCIATED GLENOSPHERE. DURING THE REVISION, IT WAS FOUND THAT THE SCREWS HAD MIGRATED AND CUT OUT THE POSTERIOR GLENOID. THE PATIENT WAS CONVERTED TO A HEMI-ARTHROPLASTY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4) CONCOMITANT MEDICAL PRODUCTS: 115382, COMP RVS CNTRL SCR 6.5 X 30 MM ST, 877000. THE 115370, COMP RVS TRAY CO 44 MM, 848480. THE 113618, COMP PRIMARY STEM 18 MM MICRO, 661170. XL-115363, ARCOM XL 44-36 STD HMRL BRNG, 478500. THE 405889, COMP RVS 2.7 MM DIA DRL, 055780. THE 115310, COMP RVRS SHLDR GLNSP STD 36 MM, 933470. THE 180557, COMP NLK SCR 3.5HEX 4.75X15 ST, 452670. THE 405800, COMP. REV SHLDR 9 IN STEINMANN, 132910. THE 180551, COMP LK SCR 3.5HEX 4.75X20 ST, 664220. THE 405883, COMP RVS 3.2 MM DRL, 04_310. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-02448.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENTS LEGAL COUNSEL THAT THE PATIENT UNDERWENT RIGHT SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE A FRACTURED CENTRAL SCREW AND A LOOSE GLENOSPHERE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254702 COMP RVRS 25MM BSPLT HA+ADPTR PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A 246500

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R