BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MS-30®, STEM, STANDARD, CEMENTED, 10, TAPER 12/14

    MDR report key: 19755314 · Received July 16, 2024

    Report

    Report Number
    0009613350-2024-00301
    Event Type
    Injury
    Date Received
    July 16, 2024
    Date of Event
    June 22, 2024
    Report Date
    October 11, 2024
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    UDI-DI
    00889024592391
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: ITEM # 802203802, COCR FEMORAL HEAD 12/14 TAPER 36MM +0 NECK, LOT # 31844546. ITEM # 0100351012, MS-30®, DISTAL CENTRALIZER, CEMENTED, ø 10/12, LOT # 3162572. ITEM # 8011-20-24, ALLEN MEDULLARY CEMENT PLUG 24MM, LOT # 66352085. G2: REPORT SOURCE AUSTRALIA. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF ALL RELEVANT DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. REVIEW OF THE COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. WITH THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE COULD NOT 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

    IT WAS REPORTED PATIENT UNDERWENT HIP REVISION APPROXIMATELY 2 DAYS POST IMPLANTATION DUE TO FRACTURE BELOW TIP OF FEMORAL STEM. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723340 MS-30®, STEM, STANDARD, CEMENTED, 10, TAPER 12/14 PROSTHESIS, HIP LZO ZIMMER GMBH N/A 3193941 00889024592391

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H SEE H11 NARRATIVE.