BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLORY HEAD POR FMRL 13X170MM

    MDR report key: 19446899 · Received June 3, 2024

    Report

    Report Number
    0001825034-2024-01444
    Event Type
    Injury
    Date Received
    June 3, 2024
    Date of Event
    October 5, 2023
    Report Date
    September 12, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K030055
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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: D4: EXPIRATION DATE. D6B: DEVICE NOT EXPLANTED. H6 PROPOSED 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 PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: AFTER UNDERGOING AN INITIAL RIGHT. THE PATIENT BEGAN EXPERIENCING PAIN AND DIFFICULTY AMBULATING WITH ELEVATED METAL IONS AND PSEUDOTUMOR. DURING THE REVISION, METALLOSIS WAS IDENTIFIED WITHIN THE JOINT WITH THE PSEUDOTUMOR. THE TRUNNION WAS CLEANED AND THE STEM REMAINED. THE HEAD AND ADAPTER WERE EXPLANTED AND REPLACED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THIS COMPLAINT WAS CONFIRMED BASED ON THE PROVIDED MEDICAL RECORDS. 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: US157850, ITEM NAME: M2A-MAGNUM PF CUP 50ODX44ID, LOT #: 395540. 157444, ITEM NAME: M2A-MAGNUM MOD HD SZ 44MM 44MM, LOT #: 297020. 139252, ITEM NAME: M2A-MAGNUM 42- 50MM TPR INSRT-6 0/-6MMT1, LOT #: 133250. 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 10 YEARS AND 9 MONTHS POST IMPLANTATION DUE TO PAIN, DIFFICULTY AMBULATING, ELEVATED METAL ION LEVELS AND A PSEUDOTUMOR. DURING THE REVISION SIGNIFICANT METALLOSIS WAS NOTED. THE STEM WAS FOUND TO HAVE SIGNIFICANT INGROWTH THEREFORE NOT EXPLANTED, THE HEAD WAS REVISED WITHOUT COMPLICATIONS. THERE IS NO ADDITIONAL INFORMATION AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1939769 MALLORY HEAD POR FMRL 13X170MM PROSTHETIC, HIP LPH ZIMMER BIOMET, INC. N/A 042090

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention| H PLEASE SEE H11.