BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN ADAPTER

    MDR report key: 21558600 · Received March 10, 2025

    Report

    Report Number
    0001825034-2025-00612
    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
    LPH
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MFR NUMBER. THIS REPORT SHOULD BE VOIDED AND A CORRECTED REPORT WAS FILED UNDER MFR NUMBER 3002806535-2025-00117. SECTIONS UPDATED: B4 B5 G2 G6 H2 H11

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 650-1058, ITEM NAME: CER BIOLOXD OPTION HD 40MM, LOT #: 3213632, UNKNOWN ADAPTER. 51-104160, ITEM NAME: TPRLC 133 T1 PPS HO 16X152MM, LOT #: 6994024. 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

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MFR NUMBER. THIS REPORT SHOULD BE VOIDED AND A CORRECTED REPORT WAS FILED UNDER MFR NUMBER 3002806535-2025-00117.

    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
    2090340 UNKNOWN ADAPTER PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. NI

    Patients

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