BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BI METRIC/XR STD RPP C/LES 7MM

    MDR report key: 20173192 · Received September 9, 2024

    Report

    Report Number
    0001825034-2024-02172
    Event Type
    Injury
    Date Received
    September 9, 2024
    Date of Event
    August 20, 2024
    Report Date
    March 2, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K052089
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED. UPDATED: H6 SUGGESTED COMPONENT CODE: MECHANICAL (G04) - 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: 157442, ITEM NAME: M2A-MAGNUM MOD HD SZ 42MM, LOT #: 201160; US157848, ITEM NAME: M2A-MAGNUM PF CUP 48ODX42ID, LOT #: 070500. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT¿S LOCATION IS NOT KNOWN; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO THE PATIENT'S COMPLAINT OF PAIN IN THE RIGHT HIP THAT WAS CONSERVATIVELY TREATED FOR SEVERAL YEARS BUT NEVER FELT RIGHT. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1536833 BI METRIC/XR STD RPP C/LES 7MM PROSTHETIC, HIP LPH ZIMMER BIOMET, INC. N/A 868550

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R PLEASE SEE H11.