BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVRS 25MM BSPLT HA+ADPTR

    MDR report key: 7295945 · Received February 26, 2018

    Report

    Report Number
    0001825034-2018-01408
    Event Type
    Injury
    Date Received
    February 26, 2018
    Date of Event
    July 12, 2016
    Report Date
    February 23, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    PK120121
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 01404, 0001825034 - 2018 - 01405, 0001825034 - 2018 - 01406, 0001825034 - 2018 - 01407. CONCOMITANT MEDICAL PRODUCTS: 113631 COMP PRIMARY STEM 11MM MINI LOT 958170, 115340 COMP RVS HMRL TI TRAY 44MM LOT 266170, XL-115363 ARCOM XL 44-36 STD HMRL BRNG LOT 118220, 115310 COMP RVRS SHLDR GLNSP STD 36MM LOT 183450, 115381 COMP RVS CNTRL SCR 6.5X25MM ST LOT 424370, 180503 COMP LOCKING SCREW 4.75X30MM LOT 801940, 180504 COMP LOCKING SCREW 4.75X35MM LOT 460530, 180513 COMP NON-LCKNG SCREW 4.75X45MM LOT 402380. REPORT SOURCE: FOREIGN. THE EVENT OCCURRED IN (B)(6). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. 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. THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN CLINICAL STUDY 482 THE PATIENT HAD PAIN 3 YEARS POST TOTAL SHOULDER ARTHROPLASTY. THE PAIN WAS REPORTED AT A LEVEL OF 7 ON A SCALE OF 10 AND THE PATIENT TOOK NON-NARCOTIC PAIN MEDICATION FOR THIS. THE PATIENT WAS UNABLE TO SLEEP ON THE AFFECTED SIDE, UNABLE TO WASH THEIR BACK, UNABLE TO LIFT 10 POUNDS ABOVE THEIR SHOULDER, UNABLE TO THROW A BALL AND UNABLE TO DO SPORTS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139561 COMP RVRS 25MM BSPLT HA+ADPTR PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A 566470

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other