BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRABECULAR METAL 56MM CUP SIZE REVISION SHELL

    MDR report key: 24835392 · Received April 9, 2026

    Report

    Report Number
    3005751028-2026-00023
    Event Type
    Injury
    Date Received
    April 9, 2026
    Report Date
    April 9, 2026
    Manufacturer
    ZIMMER TMT
    Product Code
    LPH
    UDI-DI
    00889024310872
    PMA / PMN Number
    K003181
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 00489405810 - TRABECULAR METAL ACETABULAR REVISION SYSTEM ACETABULAR AUGMENT - 63392067; 00625006550 - BONE SCREW SELF-TAPPING 6.5 MM DIA. 50 MM LENGTH - 64561604; 00662406550 - BONE SCREW SELF-TAPPING 50 MM LENGTH 6.5 MM DIA. - 63704590; 00662406540 - BONE SCREW SELF-TAPPING 40 MM LENGTH 6.5 MM DIA. - 64645209; 11-300814 - ARCOS 14 X 150 MM SPL TPR DIST - 774180; 11-300818 - ARCOS 18 X 150 MM SPL TPR DIST - 147420; 010000903 - G7 10 DEG E1 LINER 40 MM F - 3743858; 11-301331 - ARCOS CON SZ A HI 70 MM - 138850; 650-1058 - CER BIOLOXD OPTION HD 40 MM - 2993268; 650-1067 - CER OPTION TYPE 1 TPR SLEVE +3 - 3031106. H10: THIS DEVICE WAS ERRONEOUSLY REPORTED UNDER AN INCORRECT MFR, AND IS NOW BEING SUBMITTED UNDER THE APPROPRIATE MFR. SEE ORIGINAL REPORT 0001822565-2024-02532. THE EVENT CANNOT BE CONFIRMED. NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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 PATIENT UNDERWENT A HIP SURGERY. SUBSEQUENTLY THE PATIENT IS EXPERIENCING PAIN AND IS PLANNING TO BE REVISED DUE TO A LOOSE CUP. THE REVISION DATE HAS NOT YET BEEN SCHEDULED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334273 TRABECULAR METAL 56MM CUP SIZE REVISION SHELL PROSTHESIS, KNEE LPH ZIMMER TMT 64564812 00889024310872

    Patients

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