BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL HEAD

    MDR report key: 11901502 · Received May 28, 2021

    Report

    Report Number
    0002648920-2021-00137
    Event Type
    Injury
    Date Received
    May 28, 2021
    Date of Event
    May 3, 2021
    Report Date
    September 27, 2021
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    LPH
    UDI-DI
    008890241444675
    PMA / PMN Number
    K953337
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: B4, B5, G3, H2, H3, H4, H6. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. 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. 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). CAT# 00811400110, FEMORAL STEM 12 LOT# 64560587. CAT# 63.32.50, LOW PROFILE CUP 32/50, LOT# 2881338. FOREIGN: (B)(6). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, AS THE DEVICE REMAINS IMPLANTED; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT HAD A FALL AT HOME CAUSING AN ACETABULAR DISLOCATION. DURING THE SURGERY IT WAS NOTED THAT THE PATIENT HAD AN INFECTION SO NO NEW IMPLANTS WERE PUT IN. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797874 FEMORAL HEAD PROSTHESIS, HIP LPH ZIMMER MANUFACTURING B.V. N/A 64349710 008890241444675

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O SEE H10 NARRATIVE