BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXILOCK TI HA STEM, 12MM

    MDR report key: 10000185 · Received April 27, 2020

    Report

    Report Number
    3005751028-2020-00033
    Event Type
    Injury
    Date Received
    April 27, 2020
    Report Date
    April 23, 2020
    Manufacturer
    ZIMMER TMT
    Product Code
    LWJ
    PMA / PMN Number
    K022966
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO CLINICAL RECORDS, IMAGES, OR DEVICES WERE RETURNED FOR REVIEW. THE PATIENT¿S MEDICAL CONDITION CAN LEAD TO PAIN IN THE JOINTS DUE TO EASY BRUISING AND HYPEREXTENSION. AS NO ADDITIONAL RECORDS HAVE BEEN PROVIDED, THE DIAGNOSIS ALONE CANNOT RULE OUT THE DEVICE AS THE CAUSE OF THE PAIN IN THIS PATIENT AND DOES NOT ACCOUNT FOR THE ADDITIONAL ALLEGATIONS. A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. A 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. CONCOMITANT MEDICAL PRODUCTS: 01-100-28002, HEAD SUPERPOLISH 28MM OD +0 NL, LOT UNKNOWN. 02-210-00523, TRABECULAR METAL¿¢ ACETABULAR REVISION SHELL, LOT UNKNOWN. 00630504828, LINER STANDARD 28 MM I.D. FOR USE WITH 48 MM O.D. SHELL, LOT 69078700.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 17 YEARS POST IMPLANTATION, THE PATIENT IS EXPERIENCING PAIN. IT WAS ALSO REPORTED THAT X-RAYS IDENTIFIED OSTEOLYSIS. PATIENT HAS ALSO HAD ALLEGATIONS OF INCREASED MEMORY ISSUES, INCOMPLETE SENTENCES, AND SPEECH PROBLEMS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466518 PROXILOCK TI HA STEM, 12MM PROSTHESIS, HIP LWJ ZIMMER TMT N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other