BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVRS SHLDR GLNSP STD 36MM

    MDR report key: 7296588 · Received February 26, 2018

    Report

    Report Number
    0001825034-2018-01478
    Event Type
    Injury
    Date Received
    February 26, 2018
    Date of Event
    September 14, 2015
    Report Date
    February 26, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PAO
    PMA / PMN Number
    PK080642
    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). MEDICAL DEVICES: 115340, COMP RVS HMRL TI TRAY 44MM, 945490, XL-115364, ARCOM XL 44-36 STD +3 HMRL BRG, 372480, 113629, COMP PRIMARY STEM 9MM MINI, 125640, 010000589, COMP RVRS 25MM BSPLT HA+ADPTR, 778660, 115382, COMP RVS CNTRL SCR 6.5X30MM ST, 448390, 180505, COMP LOCKING SCREW 4.75X40MM, 544910, 180505, COMP LOCKING SCREW 4.75X40MM, 402260. REPORT SOURCE, FOREIGN - THE EVENT OCCURRED IN (B)(6). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. THE PRODUCT WAS NOT RETURNED FOR THE INVESTIGATION, THEREFORE A VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORT EVENT WAS NOT REPORTED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 01475, 0001825034 - 2018 - 01476, 0001825034 - 2018 - 01477, 0001825034 - 2018 - 01479.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT LEFT SHOULDER SURGERY AND DURING THE 6-MONTH FOLLOW UP VISIT THE PATIENT REPORTED LEVEL 7 PAIN (PAIN SCORE 0=NO PAIN-10=WORST PAIN) WITH DIFFICULTY PERFORMING DAILY ACTIVITIES AND TAKING NO PAIN MEDICATION. PATIENT REPORTED FEELING THAT THEIR SHOULDER WAS UNSTABLE (AS IF IT WAS GOING TO DISLOCATE) AT LEVEL 3 (0 BEING VERY STABLE, 10 BEING VERY UNSTABLE). AT 1-YEAR FOLLOW UP VISIT, THE PATIENT REPORTED LEVEL 8 PAIN (PAIN SCORE 0=NO PAIN-10=WORST PAIN) WITH DIFFICULTY PERFORMING DAILY ACTIVITIES AND TAKING NO PAIN MEDICATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140098 COMP RVRS SHLDR GLNSP STD 36MM PROSTHESIS, SHOULDER PAO ZIMMER BIOMET, INC. N/A 755010

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other