BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FITMORE, SHELL WITH SCREW CONES, UNCEMENTED, 54/JJ

    MDR report key: 17030447 · Received May 31, 2023

    Report

    Report Number
    0009613350-2023-00235
    Event Type
    Malfunction
    Date Received
    May 31, 2023
    Date of Event
    March 27, 2023
    Report Date
    May 31, 2023
    Manufacturer
    ZIMMER MANUFACTURING SWITZERLAND GMBH
    Product Code
    LZO
    UDI-DI
    00889024384347
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) D10: FITMORE, SHELL WITH SCREW CONES, UNCEMENTED, 54/JJ, ITEM# 0100024554, LOT# UNKNOWN FITMORE, HIP STEM, UNCEMENTED, B/7, TAPER 12/14, ITEM# 0100551207, LOT# 3120204 BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 36/0, TAPER 12/14, ITEM# 00877503602, LOT# 3130986 G2- FOREIGN - ITALY MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0009613350-2023-00164. THE INSERT WAS RETURNED FOR INVESTIGATION, HOWEVER NO SHELL WAS RECEIVED. THE INSERT SHOWS SOME SMALL SCRATCHES AND NICKS BOTH ON THE ARTICULATING SURFACE AND THE NON-ARTICULATING SURFACE. THE FLAT RIM OF THE INSERT SHOWS SOME DEEP SCRATCHES. REVIEW OF MANUFACTURING RECORDS CANNOT BE PERFORMED WITHOUT PRODUCT IDENTIFICATION. DEVICES ARE USED FOR TREATMENT. AN UNDATED X-RAY SHOWING AN AP VIEW OF THE LEFT HIP WAS RECEIVED, BUT DOES NOT PROVIDE ADDITIONAL INFORMATION FOR THE INVESTIGATION. WITH THE AVAILABLE INFORMATION A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISH. 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 THAT THE INSERT DID NOT FIT INTO THE CUP DURING THE HIP IMPLANTATION. THE SURGERY WAS COMPLETED WITH ANOTHER INSERT AND ANOTHER CUP WITHOUT ANY COMPLICATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1029711 FITMORE, SHELL WITH SCREW CONES, UNCEMENTED, 54/JJ HIP PROSTHESIS LZO ZIMMER MANUFACTURING SWITZERLAND GMBH N/A UNKNOWN 00889024384347

    Patients

    Seq Age Sex Outcome Treatment
    1 Male