BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E1 44-36 STD HMRL BRNG

    MDR report key: 7966785 · Received October 15, 2018

    Report

    Report Number
    0001825034-2018-09288
    Event Type
    Injury
    Date Received
    October 15, 2018
    Date of Event
    September 18, 2018
    Report Date
    February 5, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PAO
    PMA / PMN Number
    PK113121
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. BEARING AND RINGLOCK WITH OUT THE TRAY ARE RETURNED FOR EVALUATION. VISUAL INSPECTION SHOWED THAT THE BEARING WAS DAMAGED AT THE LIP AND SLOT POSSIBLY DUE TO THE BENT RING LOCK. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES 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 IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. (B)(4). CONCOMITANT MEDICAL PRODUCTS: 010000589, COMP RVRS 25MM BSPLT HA+ADPTR, 163320; 110004347, SIG GLEN CT GD/BONE MODEL SET, 474650; 113615, COMP PRIMARY STEM 15MM MICRO, 595350; 115310, COMP RVRS SHLDR GLNSP STD 36MM, 837030; 115370, COMP RVS TRAY CO 44MM, 397550; 115395, COMP RVS CNTRL 6.5X25MM ST/RST, 043200; 180550, COMP LK SCR 3.5HEX 4.75X15 ST, 426330; 180551, COMP LK SCR 3.5HEX 4.75X20 ST, 220010; 180552, COMP LK SCR 3.5HEX 4.75X25 ST, 603170; 406669, STN PN THD TIP .125X2.5IN 2PK, 222510; 106021, RINGLOC+ REPLACEMENT RING SZ21, 684250. EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PRIMARY COMPREHENSIVE REVERSE SHOULDER PROCEDURE, THE POLY LINER FAILED TO SEAT INTO THE HUMERAL TRAY. FINAL SEATING DID NOT RESULT IN THE RING-LOCK MECHANISM CORRECTLY LOCKING. THE PROCEDURE WAS COMPLETED WITH A NEW LINER. RESULTANT CONSTRUCT WAS TIGHTER THAN IDEAL, AND EXTRA BONE REMOVAL WAS REQUIRED TO PREVENT IMPINGEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806260 E1 44-36 STD HMRL BRNG PROSTHESIS, SHOULDER PAO ZIMMER BIOMET, INC. N/A 536010

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention