BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE FIXED LOCKING SCREW

    MDR report key: 7947426 · Received October 9, 2018

    Report

    Report Number
    0001825034-2018-09199
    Event Type
    Injury
    Date Received
    October 9, 2018
    Date of Event
    March 5, 2017
    Report Date
    March 7, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    PK132239
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. OP NOTES DATED FOR THIS REVISION NOTE THAT AS SOON AS THE SURGEON OPENED THROUGH THE DELTOID FASCIA, THEY ENCOUNTERED CLOUDY FLUID, WHICH WAS CULTURED WITH ATTEMPTED REDUCTION OF THE SHOULDER. THE HUMERAL COMPONENT WAS STILL IMPINGING WITH THE INTACT INFERIOR GLENOID, AS WAS EXPECTED FROM THE RADIOGRAPHS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION 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.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. UNIQUE IDENTIFIER (UDI) #: (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM # 115378, COMP RVS TRAY +10MM CO 44MM, LOT #905990; ITEM # XL-115363, ARCOM XL 44-36 STD HMRL BRNG, LOT # 884300; ITEM # 180550, COMP LK SCR 3.5HEX 4.75X15 ST, LOT # 331030; ITEM # 180554, COMP LK SCR 3.5HEX 4.75X35 ST, LOT # 028240; ITEM # 010000589, COMP RVRS 25MM BSPLT HA+ADPTR, LOT # 017540; ITEM # 115310, COMP RVRS SHLDR GLNSP STD 36MM, LOT # 961680; ITEM # 115396, COMP RVS CNTRL 6.5X30MM ST/RST, LOT # 391730; ITEM # 406669, STN PN THD TIP .125X2.5IN 2PK, LOT # 354400; ITEM # 113635, COMP PRIMARY STEM 15MM MINI, LOT # 231180. LEGAL NOTIFICATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-09193, 0001825034-2018-09194, 0001825034-2018-09195, 0001825034-2018-09196, 0001825034-2018-09197, 0001825034-2018-09198, 0001825034-2018 09200, 0001825034-2018-09201, 0001825034-2018-09202.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY THREE (3) MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT A REVISION TO HAVE THE SHOULDER PROSTHESIS REMOVED WITH IRRIGATION AND DEBRIDEMENT AND THE PLACEMENT OF AN ANTIBIOTIC SPACER. IT IS FURTHER ALLEGED THAT THE PATIENT CONTINUED TO HAVE ANTIBIOTIC TREATMENT FOR INFECTION FROM THE 2ND REVISION, UNTIL PRESENT TIME. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788900 COMPREHENSIVE REVERSE FIXED LOCKING SCREW PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A 135680

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R