BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM CONSTR. LINER +5 SZ 24

    MDR report key: 7183093 · Received January 11, 2018

    Report

    Report Number
    0001825034-2018-00208
    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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. PRODUCT WAS NOT EXPLANTED REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES 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.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 16-116054 RNGLC+ LTD HOLE SHELL SZ54 LOT 209010, 103531 TI LOW PROFILE SCREW 6.5 X 20 MM LOT 873610, 103533 TI LOW PROFILE SCREW 6.5 X 30 MM LOT 791100, 150481 DIAH SEG LOCK SCREW SET LOT 377550, 31-323230 3.2 MM X 30 MM RNGLC+ ACET DRL BIT LOT 784190. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED APPROXIMATELY ONE YEAR POST-IMPLANTATION DUE TO DISLOCATION. THE FEMORAL HEAD WAS SWAPPED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27324 FREEDOM CONSTR. LINER +5 SZ 24 PROSTHESIS, HIP KWZ ZIMMER BIOMET, INC. N/A 002750

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R