BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMP NLK SCR 3.5HEX 4.75X20 ST

    MDR report key: 7944844 · Received October 8, 2018

    Report

    Report Number
    0001825034-2018-09156
    Event Type
    Malfunction
    Date Received
    October 8, 2018
    Date of Event
    September 7, 2016
    Report Date
    March 19, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    K130390
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOW UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION RECEIVED: UDI: (B)(4). CONCOMITANT MEDICAL PRODUCTS : 118001 VERSA-DIAL/COMP TI STD TAPER 323550, 115310 COMP RVRS SHLDR GLNSP STD 36MM 463660, 113633 COMP PRIMARY STEM 13MM MINI 040020, 115375 COMP RVS TRAY +5MM CO 44MM 327300, XL-115364 ARCOM XL 44-36 STD +3 HMRL BRG 449900, 115330 COMP RVRS SHDR GLEN BSPLT +HA 951760, 180552 COMP LK SCR 3.5HEX 4.75X25 ST 096610, 180559 COMP NLK SCR 3.5HEX 4.75X25 ST 287790, 115397 COMP RVS CNTRL 6.5X35MM ST/RST 864340. THE COMPLAIN IS UNDER INVESTIGATION. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT CAN BE CONFORMED BASED ON OPERATIVE RECORDS PROVIDED STATING THE GLENOID COMPONENT WAS GROSSLY LOOSE. THE GLENOID AND GLENOSPHERE WERE REMOVED WITHOUT DIFFICULTY. THERE WAS A FRACTURE OF THE INFERIOR THIRD OF THE GLENOID, WHICH WAS THE CAUSE OF THE GLENOID LOOSENING, . 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 REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT UNDERWENT INITIAL LEFT SHOULDER ARTHROPLASTY, AND SUBSEQUENTLY UNDERWENT A REVISION APPROXIMATELY ONE YEAR POST IMPLANTATION DUE TO LOOSENING OF GLENOID COMPONENT SECONDARY TO A GLENOID BONE FRACTURE. PAIN AND DECREASED RANGE OF MOTION HAD BEEN REPORTED PRIOR TO THE REVISION PROCEDURE. NO OTHER COMPLICATIONS WERE NOTED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: UNKNOWN HUMERAL STEM; UNKNOWN HUMERAL BEARING; UNKNOWN GLENOSPHERE; UNKNOWN GLENOID BASE PLATE. THE COMPLAINT IS IN INVESTIGATION, ONCE THE INVESTIGATION IS COMPLETED A FOLLOW UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT(S): 0001825034 - 2018 - 09155; 0001825034 - 2018 - 09157; 0001825034 - 2018 - 09158; 0001825034 - 2018 - 09160.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT LEFT SHOULDER ARTHROPLASTY. SUBSEQUENTLY, PATIENT WAS REVISED ONE YEAR POST IMPLANTATION DUE TO ARTHRITIS. NO ADDITIONAL INFORMATION IS MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786396 COMP NLK SCR 3.5HEX 4.75X20 ST PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A 287780

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R