BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 HI-WALL E1 LINER 36MM F

    MDR report key: 8235770 · Received January 10, 2019

    Report

    Report Number
    0001825034-2019-00096
    Event Type
    Malfunction
    Date Received
    January 10, 2019
    Report Date
    July 18, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    K121874
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO 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.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANT DATE- 2017 PPS LTD ACET SHELL 54F PN (B)(4). LN6033366. CLS FEMORAL STEM (B)(4). LN 2905069. BIOLOX DELTA FEMORAL HEAD (B)(4) LN 2904670. REPORTING SOURCE- (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 THAT A PATIENT IS EXPERIENCING A NOISY IMPLANT APPROXIMATELY A YEAR AFTER SURGERY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29994 G7 HI-WALL E1 LINER 36MM F PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. N/A 6099125

    Patients

    Seq Age Sex Outcome Treatment
    1