BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LG HYBRID GLENOID BASE 4MM

    MDR report key: 15056774 · Received July 19, 2022

    Report

    Report Number
    0001825034-2022-01653
    Event Type
    Injury
    Date Received
    July 19, 2022
    Date of Event
    June 16, 2022
    Report Date
    October 3, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSD
    PMA / PMN Number
    K193038
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: LG HYBRID GLENOID BASE 4MM CAT: 113956 LOT: 113956. VERSA-DIAL 50X21X57 HUM HEAD CAT: 113053 LOT: 022950. COMPR NANO HMRL PPS 40MM CAT: 115740 LOT: 239820. VERSA-DIAL/COMP TI STD TAPER PR ADAPTOR CAT: 118001 LOT: 090990. PT HYBRID GLEN POST REGENEREX GENEREX CAT: PT-113950 LOT: 451180. REPORT SOURCE: FOREIGN: UK. IT IS UNKNOWN IF PRODUCT WILL BE RETURNING TO ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THE DEVICE WAS PREVIOUSLY INVESTIGATED ON MEDWATCH#: 0001825034-2020-01177. 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 DISLOCATION. THE PATIENT HAD UNDERWENT A PREVIOUS SUBSCAPULARIS REPAIR AFTER DISLOCATION/ INSTABILITY. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE 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
    241939 LG HYBRID GLENOID BASE 4MM SHOULDER, PROSTHESIS HSD ZIMMER BIOMET, INC. 113956

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| H