BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM

    MDR report key: 19656861 · Received July 2, 2024

    Report

    Report Number
    0001822565-2024-02217
    Event Type
    Injury
    Date Received
    July 2, 2024
    Date of Event
    April 30, 2024
    Report Date
    August 29, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSD
    PMA / PMN Number
    K052906
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - MEDICAL PRODUCT: CATALOG #: 180560, COMP NLK SCR 3.5HEX 4.75X30 ST, LOT #976370. CATALOG #: 180560, COMP NLK SCR 3.5HEX 4.75X30 ST, LOT #979490. CATALOG #: 180555, COMP LK SCR 3.5HEX 4.75X40 ST, LOT #017930. CATALOG #: 115396, COMP RVS CNTRL 6.5X30MM ST/RST, LOT# 017690. CATALOG #: 180552, COMP LK SCR 3.5HEX 4.75X25 ST, LOT #533810. CATALOG #: 115330, COMP RVRS SHDR GLEN BSPLT +HA, LOT #247470. CATALOG #: 110030776, STANDARD OFFSET 40MM DIAMETER GLENOSPHERE, LOT # 65026824. G2: AUSTRALIA. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT WAS REQUESTED BUT NOT RETURNED TO THE HOSPITAL. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THE REPORTED EVENT IS UNABLE TO BE CONFIRMED FOR THE ITEMS ON THIS COMPLAINT. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: TWO VIEWS LEFT SHOULDER DEMONSTRATE A REVERSE TOTAL SHOULDER ARTHROPLASTY WITH FRACTURED SCREWS AND RESULTING GLENOHUMERAL DISLOCATION. REVIEW OF THE PROVIDED INFORMATION INDICATES THAT THE INSTABILITY AND PAIN REPORTED ARE THE RESULTING IMPACT OF THE LOSS OF FIXATION/SCREW BREAKAGE. THE PRIMARY FAILURE IS THE SCREW FRACTURE AND LOSS OF FIXATION WHICH IS CAPTURED ON A SEPARATE LINKED COMPLAINT. THEREFORE, NO PROBLEM WAS FOUND WITH THE REPORTED ITEMS ON THIS COMPLAINT. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. 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

    IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOSS OF FIXATION DUE TO BONE GRAFT RESORPTION, SCREW BREAKAGE, INSTABILITY, AND PAIN. THE GLENOSPHERE AND BASEPLATE WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756587 ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM EXTREMITY IMPLANT HSD ZIMMER BIOMET, INC. N/A 62438566

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H SEE H10.