BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVRS 25MM BSPLT HA+ADPTR

    MDR report key: 17346374 · Received July 18, 2023

    Report

    Report Number
    0001825034-2023-01638
    Event Type
    Injury
    Date Received
    July 18, 2023
    Date of Event
    July 6, 2023
    Report Date
    October 31, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    UDI-DI
    00880304532465
    PMA / PMN Number
    K193373
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: MEDICAL PRODUCT: COMP RVRS SHLDR GLNSP STD 36MM: CATALOG#115310, LOT#J7283862. ARCOM XL 44-36 STD HMRL BRNG: CATALOG#XL-115363, LOT#796370. COMP RVS TRAY CO 44MM: CATALOG#115370, LOT#243920. COMP PRIMARY STEM 12MM MINI: CATALOG#113632, LOT#65025568. COMP RVS CNTRL 6.5X30MM ST/RST: CATALOG#115396, LOT#124340. COMP RVS CNTRL 6.5X20MM ST/RST: CATALOG#115394, LOT#493840. COMP NLK SCR 3.5HEX 4.75X25 ST: CATALOG#180559, LOT#806190, QTY2. COMP NLK SCR 3.5HEX 4.75X20 ST: CATALOG#180558, LOT#NI. COMP NLK SCR 3.5HEX 4.75X20 ST: CATALOG#180558, LOT#877810. COMP RVS CNTRL 6.5X25MM ST/RST: CATALOG#115395, LOT#242650. G2: FOREIGN: ITALY. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR EVALUATION. THE INVESTIGATION IS IN PROGRESS. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    VISUAL EXAMINATION OF THE RETURNED PRODUCT AND PROVIDED PICTURES IDENTIFIED THE GLENOSPHERE WAS RETURNED WITH THE TAPER ADAPTER ATTACHED. THE BASEPLATE WAS NOT RETURNED. THERE ARE SCRATCHES ON THE POLISHED SURFACE OF THE GLENOSPHERE AS WELL AS THE TAPER ADAPTER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: IMPLANT FIT IS MAINTAINED. THE GLENOSPHERE IS DISASSOCIATED AS NOTED. BONE QUALITY IS OSTEOPENIC. THERE IS MALALIGNMENT SECONDARY TO THE DISASSOCIATED GLENOSPHERE AS NOTED. NO IMPLANT LOOSENING OR OTHER ABNORMALITY. NO OTHER CONCERNS OR SIGNS OF TRAUMA ARE IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. THE REPORTED EVENT IS CONFIRMED BY HEALTHCARE PROFESSIONAL REVIEW OF PROVIDED X-RAY IMAGES. 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 THAT A PATIENT UNDERWENT AN INITIAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, SEVEN (7) MONTHS POST-IMPLANTATION, THE PATIENT BEGAN TO EXPERIENCE PAIN AND UNDERWENT REVISION SURGERY DUE TO DISASSOCIATION OF THE SHOULDER PROSTHESIS. ALL COMPONENTS WERE REVISED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862420 COMP RVRS 25MM BSPLT HA+ADPTR PROSTHESIS, SHOULDER PHX ZIMMER BIOMET, INC. 010000589 750880 00880304532465

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| H