BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM CONSTR HD 36MM T1 STD

    MDR report key: 7183178 · Received January 11, 2018

    Report

    Report Number
    0001825034-2018-00209
    Event Type
    Injury
    Date Received
    January 11, 2018
    Date of Event
    May 18, 2016
    Report Date
    January 17, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWZ
    PMA / PMN Number
    PK030047
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 11-107023, FREEDOM CONSTR. LINER +5 SZ 24, 002750. 16-116054, RNGLC+ LTD HOLE SHELL SZ54, 209010. 103531, TI LOW PROFILE SCREW 6.5 X 20 MM, 873610. 103533, TI LOW PROFILE SCREW 6.5 X 30 MM, 791100. 150481, DIAH SEG LOCK SCREW SET, 377550. 31-323230, 3.2 MM X 30 MM RNGLC+ ACET DRL BIT, 784190. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-00208.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. 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 · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED APPROXIMATELY ONE YEAR POST-IMPLANTATION DUE TO DISLOCATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26600 FREEDOM CONSTR HD 36MM T1 STD PROSTHESIS, HIP KWZ ZIMMER BIOMET, INC. N/A 295110

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R