BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVENIR MLLER, STEM, STANDARD, UNCEMENTED, HA, 4, TAPER 12/14

    MDR report key: 12317959 · Received August 13, 2021

    Report

    Report Number
    0009613350-2021-00403
    Event Type
    Injury
    Date Received
    August 13, 2021
    Date of Event
    July 28, 2021
    Report Date
    November 15, 2021
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    LZO
    UDI-DI
    00889024590977
    PMA / PMN Number
    K123392
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NOTE: IN ONE OF THE FOLLOW-UP RESPONSES IN THE COMPLAINT, IT WAS STATED THAT THE LEFT HIP CAUSED THE PAIN AND LIMPING, NOT THE RIGHT HIP (WHICH IS WHERE ZB DEVICES ARE IMPLANTED). BECAUSE OF THIS, IT IS NOW CLEAR THAT THE COMPLAINED PRODUCTS ARE NOT ZIMMER BIOMET PRODUCTS. THEREFORE, PLEASE DELETE THIS REPORT FROM YOUR SYSTEM: (B)(4) / MFR: 0009613350-2021-00403-1.

    Description of Event or Problem · 0

    NOTE: IN ONE OF THE FOLLOW-UP RESPONSES IN THE COMPLAINT, IT WAS STATED THAT THE LEFT HIP CAUSED THE PAIN AND LIMPING, NOT THE RIGHT HIP (WHICH IS WHERE ZB DEVICES ARE IMPLANTED). BECAUSE OF THIS, IT IS NOW CLEAR THAT THE COMPLAINED PRODUCTS ARE NOT ZIMMER BIOMET PRODUCTS. THEREFORE, PLEASE DELETE THIS REPORT FROM YOUR SYSTEM: (B)(4) / MFR: 0009613350-2021-00403-1.

    Additional Manufacturer Narrative · 1

    MEDICAL PRODUCTS: ALLOFIT-S IT ALLOCLASSIC, SHELL FOR ACETABULUM, UNCEMENTED, 52/II; CATALOG#: 00-8755-052-02; LOT#: 2737388. BIOLOX DELTA, CERAMIC FEMORAL HEAD, L, 36/+3.5, TAPER 12/14; CATALOG#: 00-8775-036-03; LOT#: 2735781. LINER NEUTRAL 36 MM I.D. SIZE II FOR USE WITH 52 MM O.D. SIZE II SHELL; CATALOG#: 00-8751-010-36; LOT#: 62519395. ALLOFIT IT ALLOCLASSIC, SHELL FOR ACETABULUM, UNCEMENTED, 50/HH; CATALOG#: 00-8755-050-00; LOT#: 2756567. THERAPY DATE: UNKNOWN. THE MANUFACTURER RECEIVED OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. 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 7 YEARS POST IMPLANTATION STARTED EXPERIENCING PAIN, SEVERE LIMP AND DIFFICULTY WITH ADLS. NO INTERVENTION HAS BEEN REPORTED YET. A LEG DISCREPANCY OF 0.8 CM HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1217055 AVENIR MLLER, STEM, STANDARD, UNCEMENTED, HA, 4, TAPER 12/14 AVENIR MULLER STEM LZO ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 4020629 00889024590977

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization SEE H10 NARRATIVE.