BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STANDARD LINER

    MDR report key: 7826224 · Received August 29, 2018

    Report

    Report Number
    0001822565-2018-04683
    Event Type
    Injury
    Date Received
    August 29, 2018
    Report Date
    June 25, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK990135
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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

    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 REMAINS IMPLANTED. CONCOMITANT MEDICAL PRODUCTS: ITEM NUMBER: 01-220-12361, ITEM NAME: FEMORAL STEM, LOT #: 00101090. ITEM NUMBER: 01-100-28002, ITEM NAME: COCR-FEMORAL HEAD, LOT #: 0011684. ITEM NUMBER: 02-210-00521, ITEM NAME: UNKNOWN, LOT #: 00107007. 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 WAS REPORTED PATIENT IS EXPERIENCING PAIN AND OSTEOLYSIS APPROXIMATELY 17 YEARS POST-IMPLANTATION. PATIENT ALSO ALLEGES INCREASED MEMORY ISSUES, INCOMPLETE SENTENCES, LOSING TRACK OF THINGS, AND GENERAL SPEECH ISSUES. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666898 STANDARD LINER PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention