BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEMORAL STEM 12/14 NK TPR SZ 6 EXTENDED OFFSET

    MDR report key: 17325074 · Received July 14, 2023

    Report

    Report Number
    0001822565-2023-01907
    Event Type
    Malfunction
    Date Received
    July 14, 2023
    Date of Event
    June 21, 2023
    Report Date
    August 11, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    UDI-DI
    00889024131699
    PMA / PMN Number
    K192660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. H6: PROPOSED COMPONENT CODE: MECHANICAL (G04)-STEM; REPORTED EVENT WAS CONFIRMED BY REVIEW OF THE PRODUCT. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED SCRATCHES ARE SEEN NEAR THE CONICAL TAPER. THE DEVICE IS ETCHED AS ITEM NUMBER 7711-06-40 / LOT NUMBER 65236202. THE STEM WAS CONFIRMED TO BE A SIZE 4 USING OVERLAY 25-2009-695-04-D. NO PACKAGING MATERIALS WERE RETURNED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO A MANUFACTURING DEFICIENCY, AS THE RETURNED STEM MATCHES THE SIZE OF A SIZE 4 STEM, BUT WAS ETCHED TO BE A SIZE 6. A CORRECTIVE ACTION WAS OPENED AS A RESULT OF THE INVESTIGATION. 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.

    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.

    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 DURING THE PROCEDURE, THE STEM SUBSIDED WHEN INSERTING IT INTO THE FEMUR. ANOTHER BOX OF THE SAME SIZE STEM WAS OPENED AND USED TO "COMPLETE" THE PROCEDURE. IT WAS NOTED THAT THE FIRST STEM WAS VISIBLY SMALLER THAN THE SECOND. THERE WAS NO HARM OR HEALTH CONSEQUENCES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692936 FEMORAL STEM 12/14 NK TPR SZ 6 EXTENDED OFFSET PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. NI 65236202 00889024131699

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female