BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEMMED TIBIAL COMPONENT

    MDR report key: 8208721 · Received January 2, 2019

    Report

    Report Number
    0001822565-2018-07104
    Event Type
    Injury
    Date Received
    January 2, 2019
    Date of Event
    December 4, 2018
    Report Date
    May 17, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K933785
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT SAMPLE WAS EVALUATED VIA PICTURES AND THE REPORTED EVENT WAS NOT CONFIRMED. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED SIGNS OF WEAR ON THE PRODUCT. BONE CEMENT REMAINED ON THE BACKSIDE OF THE FEMORAL COMPONENT. AS PRODUCT WAS NOT RETURNED, FURTHER EVALUATIONS COULD NOT BE PERFORMED. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 - 2018 - 07105 - 1.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). CONCOMITANT MEDICAL PRODUCTS: STEMMED TIBIAL COMPONENT; P/N: 00598003702, L/N: UNK, KNE-NEXGEN-FEMORALS-UNK; P/N: UNK, L/N: UNK, KNE-NEXGEN-BEARINGS-UNK; P/N: UNK, L/N: UNK. (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS NOT IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 - 2018 - 07104, 0001822565 - 2018 - 07105, 0001822565 - 2018 - 07106. PRODUCT LOCATION IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT A REVISION PROCEDURE DUE TO PAIN AND LOOSENING. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1567 STEMMED TIBIAL COMPONENT PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R