BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURASUL, ALPHA INSERT, JJ/36

    MDR report key: 16741752 · Received April 14, 2023

    Report

    Report Number
    0009613350-2023-00164
    Event Type
    Malfunction
    Date Received
    April 14, 2023
    Date of Event
    March 27, 2023
    Report Date
    May 31, 2023
    Manufacturer
    ZIMMER MANUFACTURING SWITZERLAND GMBH
    Product Code
    LZO
    UDI-DI
    00889024413634
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. D10: FITMORE, SHELL WITH SCREW CONES, UNCEMENTED, 54/JJ, ITEM#: 0100024554, LOT#: UNKNOWN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0009613350-2023-00235. 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. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). ASSOCIATED PRODUCTS: FITMORE, SHELL WITH SCREW CONES, UNCEMENTED, 54/JJ, ITEM# 0100024554 , LOT# 3129646 FITMORE, HIP STEM, UNCEMENTED, B/7, TAPER 12/14, ITEM# 0100551207 , LOT# 3120204 BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, ø 36/0, TAPER 12/14, ITEM# 00877503602, LOT# 3130986. FOREIGN - " ITALY". INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

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

    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 WITHOUT ANY COMPLICATION. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT. TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404856 DURASUL, ALPHA INSERT, JJ/36 HIP PROSTHESIS LZO ZIMMER MANUFACTURING SWITZERLAND GMBH N/A 3109301 00889024413634

    Patients

    Seq Age Sex Outcome Treatment
    1 Male SEE H10.