BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRABECULAR METAL GLENOID COMPONENT 52 MM ARTICULAR SURFACE

    MDR report key: 16335334 · Received February 9, 2023

    Report

    Report Number
    3005751028-2023-00002
    Event Type
    Injury
    Date Received
    February 9, 2023
    Date of Event
    September 6, 2022
    Report Date
    February 8, 2023
    Manufacturer
    ZIMMER TMT
    Product Code
    KWS
    UDI-DI
    00889024306684
    PMA / PMN Number
    K071090
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). NO PRODUCT WAS RETURNED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. NO PHOTOGRAPHS OF THE ARTICULAR SURFACE WERE PROVIDED. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR DEVIATIONS AND/OR ANOMALIES WITH NO ANOMALIES/DEVIATIONS RELATED TO THE EVENT IDENTIFIED. THE STERILE CERTIFICATE WAS REVIEWED AND NOTED TO BE CONFORMING. IT WAS STERILIZED IN ACCORDANCE WITH FDA REGULATIONS AND ISO STANDARDS. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THE REPORTED PART AND LOT COMBINATION. X-RAY IMAGES WERE REVIEWED WITH THE FOLLOWING NOTED: EXTENSIVE OSTEOLYSIS INVOLVING BOTH THE HUMERAL AND GLENOID IMPLANTS WITH SUSPECTED IMPLANT LOOSENING BUT NO IMPLANT DISPLACEMENT OR DISLOCATION. THE GLENOID IMPLANT APPEARS SUBSIDED. THE ROOT CAUSE OF THE INFECTION WAS DETERMINED TO BE UNRELATED TO THE IMPLANTED ZIMMER BIOMET DEVICE. THE COMPLAINT FOR LOOSENING IS NOT CONFIRMED. A DEFINITIVE ROOT CAUSE (LOOSENING) CANNOT BE DETERMINED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. ADDITIONAL ASSOCIATED PRODUCTS 0104555130 HUMERAL ANCHOR UNCEMENTED L, LOT#: 2922197; 00430005230 MODULAR HUMERAL HEAD 30 MM HEAD HEIGHT 52 MM SPHERICAL HEAD DIAMETER, LOT#: 61194309. 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 THE PATIENT'S SHOULDER WAS REVISED DUE TO LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1169380 TRABECULAR METAL GLENOID COMPONENT 52 MM ARTICULAR SURFACE PROSTHESIS, SHOULDER KWS ZIMMER TMT N/A 63924825 00889024306684

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization| R