BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPRLC 133 T1 PPS HO 16X152MM

    MDR report key: 21558599 · Received March 10, 2025

    Report

    Report Number
    0001825034-2025-00611
    Event Type
    Malfunction
    Date Received
    March 10, 2025
    Date of Event
    February 12, 2025
    Report Date
    May 1, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    UDI-DI
    00880304491854
    PMA / PMN Number
    K200196
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. H6: COMPONENT CODE: STEM. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE COMPLAINT CANNOT BE CONFIRMED. 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). D10: 650-1058 CER BIOLOXD OPTION HD 40MM LOT #:3213632, UNKNOWN ADAPTER H6: MECHANICAL CODE: STEM . CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ADAPTER MAY NOT HAVE SEATED CORRECTLY ON THE STEM. CAUSED THE HEAD TO POTENTIALLY SIT HIGHER THAN IT SHOULD HAVE, SO DOCTOR WAS UNABLE TO REDUCE HIP. THERE WAS ROUGHLY A 10-15 MINUTE DELAY AS THE SURGEON WAS UNABLE TO REDUCE THE PATIENT¿S HIP. HE TRIED TO SEPARATE THE HEAD/TAPER FROM THE STEM, BUT THE TAPER REMAINED ON THE STEM WHILE THE HEAD SEPARATED FROM THE TAPER. HE HAD TO REPLACE THAT STEM WITH A NEW STEM AS THE TAPER WOULD NOT DISENGAGE. THE PROCEDURE WAS COMPLETED USING A NEW STEM. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2090339 TPRLC 133 T1 PPS HO 16X152MM PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. 6994024 00880304491854

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male PLEASE SEE H11.