BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAGE ONE SELECT HIP STEM CEMENT SPACER MOLD

    MDR report key: 7588794 · Received June 11, 2018

    Report

    Report Number
    0001825034-2018-03892
    Event Type
    Injury
    Date Received
    June 11, 2018
    Date of Event
    April 20, 2018
    Report Date
    February 18, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWY
    PMA / PMN Number
    PK080979
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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. 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 · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS - FREEDOM ALL POLY CUP 50MM, # ITEM 11-107122 LOT UNK, FREEDOM CONSTR HD 36MM, T1 +6MM # ITEM 11-107020 LOT UNK, PALACOS R 1X40 SINGLE # ITEM 00-1112-140-01 LOT UNK. IT IS UNKNOWN IF PRODUCT WILL BE RETURNING TO ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY OF A CEMENT MOLD STEM 7 DAYS POST STAGE 1 REVISION SURGERY. SHE WAS INSERTED WITH A CEMENT SPACER MOLD, AND WHEN SHE WAS BEING TRANSFERRED TO THE WHEELCHAIR SHE HEARD A POP AND THEN HAD PAIN. SHE WAS RE-ADMITTED TO ORTHOPEDICS 4 DAYS POST IMPLANTATION OF THE INITIAL CEMENT MOLD STEM AND UNDERWENT REVISION SURGERY. THE SURGEON FOUND THE INITIAL CEMENT MOLD TO BE BENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431263 STAGE ONE SELECT HIP STEM CEMENT SPACER MOLD PROSTHESIS HIP KWY ZIMMER BIOMET, INC. N/A 224060

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R