BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 LONGEVITY NEUTRAL 40MM G

    MDR report key: 16397006 · Received February 17, 2023

    Report

    Report Number
    0001822565-2023-00427
    Event Type
    Malfunction
    Date Received
    February 17, 2023
    Date of Event
    January 26, 2023
    Report Date
    April 18, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024518810
    PMA / PMN Number
    K190660
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. D10: 010000667 G7 PPS LTD ACET SHELL 60G 7132903. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED THERE IS DAMAGE TO THE LIP ON THE UNDERSIDE OF THE DEVICE. THE LOCKING RING HAS BEEN DEFORMED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THIS/THESE ITEM(S) AND THE REPORTED PART AND LOT COMBINATION(S). MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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

    IT WAS REPORTED THE 40 LINER DID NOT SEAT IN THE CUP. THE ISSUE OCCURRED DURING SURGERY AND ANOTHER LINER (36 SIZE NEUTRAL) WAS USED TO COMPLETE THE CASE. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127027 G7 LONGEVITY NEUTRAL 40MM G PROTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 65615454 00889024518810

    Patients

    Seq Age Sex Outcome Treatment
    1 Male