BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MLRY-HD POR FMRL 9X150MM

    MDR report key: 14016060 · Received April 5, 2022

    Report

    Report Number
    0001825034-2022-00824
    Event Type
    Injury
    Date Received
    April 5, 2022
    Date of Event
    January 31, 2018
    Report Date
    May 10, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K030055
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT PRODUCTS: M2A MAGNUM ¿ MODULAR HEAD (CAT. NO. 157444, LOT NO. 637620); M2A TAPER (CAT. NO. 139256, LOT NO. 891010); M2A PF CUP (CAT. NO. US157850, LOT NO. 055720); GPS PLATELET CONCENTRATION SEPARATION KIT (CAT. NO. 800-1003A, LOT NO. 001471). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2022 - 00820, 0001825034 - 2022 - 00821, 0001825034 - 2022 - 00822.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. H6: COMPONENT CODE: MECHANICAL (G04) - STEM COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. ONE M2A-MAGNUM MOD HD SZ 44MM WAS RETURNED AND EVALUATED. UPON VISUAL INSPECTION THERE IS SOME SCUFFING ON THE OUTSIDE RADIUS OF THE DEVICE WITH NO VISIBLE DAMAGE TO THE FACE. THERE IS NO VISIBLE DEBRIS INSIDE OF THE TAPER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO 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 THE PATIENT UNDERWENT A LEFT HIP REVISION PROCEDURE APPROXIMATELY 8 YEARS POST-IMPLANTATION. NO ADDITIONAL INFORMATION.

    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
    812760 MLRY-HD POR FMRL 9X150MM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 168570

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H SEE H10 NARRATIVE