BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPR RVS GLENO 2-PRNG INS/IMP

    MDR report key: 11992265 · Received June 14, 2021

    Report

    Report Number
    0001825034-2021-01774
    Event Type
    Malfunction
    Date Received
    June 14, 2021
    Date of Event
    June 3, 2021
    Report Date
    August 18, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    PMA / PMN Number
    K193373
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CMP-(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: B4, B5, G3, H2, H3, H6 REPORTED EVENT WAS CONFIRMED BY VISUAL EXAMINATION OF PROVIDED PHOTOGRAPH. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. VISUAL EXAMINATION OF THE PROVIDED PHOTO IDENTIFIED THE IMPACTOR PAD WAS FRACTURED. THIS DEVICE HAS A POTENTIAL FIELD AGE OF 5+ YEARS WITH AN UNKNOWN NUMBER OF USES. 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE PRODUCT CODE: (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE IMPACTOR BROKE DURING IMPACTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893459 COMPR RVS GLENO 2-PRNG INS/IMP INSTRUMENT, EXTREMITIES PHX ZIMMER BIOMET, INC. N/A 402570

    Patients

    Seq Age Sex Outcome Treatment
    1