BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLOCLASSIC STEM

    MDR report key: 12231920 · Received July 27, 2021

    Report

    Report Number
    0009613350-2021-00350
    Event Type
    Injury
    Date Received
    July 27, 2021
    Date of Event
    June 7, 2021
    Report Date
    February 24, 2022
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NOTE: THIS PRODUCT (UNKNOWN ALLOCLASSIC HIP STEM HAS BEEN MOVED TO ASSOCIATED DEVICES, AS IT TURNED OUT THAT THIS STEM WAS NOT REVISED. THEREFORE, PLEASE REMOVE THIS REPORT FROM YOUR SYSTEM. THIS INCIDENT IS COVERED IN: 0009613350-2021-00349-1, 0009613350-2021-00348-1.

    Description of Event or Problem · 0

    NOTE: THIS PRODUCT (UNKNOWN ALLOCLASSIC HIP STEM HAS BEEN MOVED TO ASSOCIATED DEVICES, AS IT TURNED OUT THAT THIS STEM WAS NOT REVISED. THEREFORE, PLEASE REMOVE THIS REPORT FROM YOUR SYSTEM.

    Additional Manufacturer Narrative · 1

    MEDICAL PRODUCTS: FITEK CUP HIP IMPL WIN GEN; CATALOG#: UNKNOWN; LOT#: UNKNOWN; METASUL SLIDING PAIR HIP IMPL WIN GEN; CATALOG#: UNKNOWN; LOT#: UNKNOWN. THERAPY DATE: (B)(6) 2021. THE MANUFACTURER RECEIVED X-RAYS AND OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER RECEIVED THE DEVICE FOR INVESTIGATION. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED ON THE RIGHT SIDE AND SUBSEQUENTLY DEVELOPED OSSIFICATIONS WHICH WAS RESECTED IN 2001. ON (B)(6) 2020 A SUDDEN STRONG MOVEMENT AND EXERCISE-DEPENDENT PAIN OCCURRED IN THE RIGHT HIP. SUBSEQUENT EXAMINATIONS REVEALED FRACTURE OF GREATER TROCHANTER WHICH WAS CAUSED DUE TO OSTEOLYSIS OR ABRASION PARTICLE REACTION TUMOR. HENCE PATIENT UNDERWENT A REVISION SURGERY, DURING WHICH DISLOCATION ALONG WITH THE TUMOR FILLED WITH MODERATE FLUID WERE REPORTED. THE PATIENT ALSO UNDERWENT BLOOD TESTS, COBALT AND CHROMIUM LEVELS WERE NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1123126 ALLOCLASSIC STEM HIP PROSTHESIS LZO ZIMMER GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Hospitalization| R SEE H10 NARRATIVE