BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM HIP SYSTEM CONSTRAINED MODULAR HEAD

    MDR report key: 6602233 · Received May 31, 2017

    Report

    Report Number
    0001825034-2017-03471
    Event Type
    Injury
    Date Received
    May 31, 2017
    Date of Event
    May 1, 2017
    Report Date
    September 14, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK043537
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION (DISCARDED). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. (B)(4). CONCOMITANT PRODUCTS: FREEDOM HIP SYSTEM CONSTRAINED MODULAR HEAD P/N 14-107017 L/N 873660. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-03472.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE IS ATTRIBUTED TO SURGEON MISUSE AS THE STEM AND HEAD SHOULD NOT BE USED TOGETHER AS THEY ARE INCOMPATIBLE. 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 · 1

    IT WAS REPORTED THAT DURING AN INITIAL TOTAL HIP PROCEDURE, TWO FEMORAL HEADS DID NOT FIT PROPERLY ON TO THE FEMORAL STEM. A THIRD FEMORAL HEAD AND NEW STEM WERE USED TO COMPLETE THE PROCEDURE. THIS RESULTED IN APPROXIMATELY A 1 HOUR DELAY IN PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383067 FREEDOM HIP SYSTEM CONSTRAINED MODULAR HEAD PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 490940

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention SEE H10