BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMP RVS TRAY CO 44MM

    MDR report key: 7014570 · Received November 9, 2017

    Report

    Report Number
    0001825034-2017-10029
    Event Type
    Malfunction
    Date Received
    November 9, 2017
    Date of Event
    September 14, 2017
    Report Date
    January 24, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    PK113069
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: XL-115363, ARCOM XL 44-36 STD HMRL BRNG, 115310. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND 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: 0001825034-2017-10031.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 115310 COMP RVRS SHLDR GLNSP STD 36M 263420, 113634 COMP PRIMARY STEM 14MM MINI 693480, 010000589 COMP RVRS 25MM BSPLT HA+ADPTR 675350, 115396 COMP RVS CNTRL 6.5X30MM ST/RST 064110, 180553 COMP LK SCR 3.5HEX 4.75X30 ST 061520, 180552 COMP LK SCR 3.5HEX 4.75X25 ST 654110, 180560 COMP NLK SCR 3.5HEX 4.75X30 ST 061810, 180558 COMP NLK SCR 3.5HEX 4.75X20 ST 185380. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. DEVICES WERE RECEIVED FOR EVALUATION; TRAY WITH LOCKING RING AND POLY BEARING. VISUAL INSPECTION OF THE DEVICES (STARING STRAIGHT DOWN INTO THE ASSEMBLY SLOT) SHOWS THE LOCKING RING IS OFFSET WITHIN THE TRAY, TOWARDS THE LEFT AND OPEN. THE POLY AND THE TRAY ARE SLIGHTLY MISALIGNED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE POLY WOULD NOT SEAT OR LOCK INTO THE TRAY AFTER REPEATED ATTEMPTS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792913 COMP RVS TRAY CO 44MM PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A 822610

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR