BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPLOR 10X22MM IMPLANT HEAD

    MDR report key: 19651334 · Received July 1, 2024

    Report

    Report Number
    0001825034-2024-01725
    Event Type
    Malfunction
    Date Received
    July 1, 2024
    Date of Event
    May 22, 2024
    Report Date
    December 16, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWI
    PMA / PMN Number
    K051385
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - MEDICAL PRODUCT: CATALOG #: 11-210061, EXPLOR 6X24MM IMPL STEM W/SCR, LOT # 508660. G2: NORWAY. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). UPDATED: B1, B4, B5, D2, D4 (EXP DATE, UDI), G3, H1, H2, H3, H4, H6, H11. MECHANICAL (G04) - HEAD. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). 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 HAD LOOSENING OF THE HEAD COMPONENT IN RELATION TO RADIAL STEM WITH 2MM LATERALIZATION AND SCREW LOOSENING. NO INTERVENTION HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD INITIAL SURGERY APPROXIMATELY 9 YEARS AGO. SUBSEQUENTLY, THE PATIENT HAD DISASSOCIATION OF THE HEAD IN RELATION TO THE STEM ABOUT 7 MONTHS AGO. THERE WAS NO TREATMENT GIVEN AS OF NOW AND NONE PLANNED.

    Description of Event or Problem · 0

    IT WAS FURTHER REPORTED THAT THE INITIAL SURGERY WAS PERFORMED APPROXIMATELY 9 YEARS AGO. PATIENT WAS ALSO NOTED TO HAVE MODERATE ARTHROSIS GLOBALLY. NO INTERVENTION IS PLANNED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    973538 EXPLOR 10X22MM IMPLANT HEAD EXTREMITY IMPLANT KWI ZIMMER BIOMET, INC. N/A 770360

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H