BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HA BIMETRIC/X POR NC STD 13MM

    MDR report key: 8823958 · Received July 24, 2019

    Report

    Report Number
    0001825034-2019-03211
    Event Type
    Injury
    Date Received
    July 24, 2019
    Date of Event
    October 25, 2016
    Report Date
    August 5, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K030055
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE DEVICE WAS NOT REMOVED DURING THE REVISION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. REPORTED EVENT WAS CONFIRMED BY REVIEW OF OPERATIVE NOTES. 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. ZIMMERBIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. CONCOMITANT MEDICAL PRODUCTS: ITEM NUMBER: 11-173661, ITEM NAME: M2A MAGNUM HEAD, LOT #: 049930; ITEM NUMBER: 15-105056 ITEM NAME: M2A 1 PC SHELL 38MMX56MM, LOT #: 970020. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-08506, 0001825034-2018-08507-2. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT AS REPORTED PATIENT UNDERWENT HIP REVISION APPROXIMATELY 9 YEARS POST-IMPLANTATION DUE TO PAIN, ELEVATED ION LEVELS, METAL POISONING, METALLOSIS, MALPOSITION OF THE ACETABULAR SHELL, PSEUDOTUMOR, PSEUDOCAPSULE, ADVERSE LOCAL TISSUE REACTION, SUBLUXATION, INSTABILITY, LIMB LENGTH DISCREPANCY AND CORROSION AROUND THE TRUNNION. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615597 HA BIMETRIC/X POR NC STD 13MM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 461530

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R