BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLUTED STEM MOBILE TIBIAL COMPONENT/PRECOAT FOR CEMENTED

    MDR report key: 7660339 · Received July 3, 2018

    Report

    Report Number
    0001822565-2018-03565
    Event Type
    Injury
    Date Received
    July 3, 2018
    Date of Event
    June 6, 2018
    Report Date
    June 6, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ARTICULAR SURFACE FOR EXPORT ONLY NOT FOR DISTRIBUTION IN THE USA SIZE E 10 MM HEIGHT, PN 00594605010, LN 62245632, FEMORAL COMPONENT OPTION FOR CEMENTED USE ONLY SIZE E RIGHT, PN 00576401552, LN 62237415 PALACOS R + G (1X40), PN 66022663, LN 762943269. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS 0001822565-2018-03566-1, 3007963827-2019-00171. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. DEVICE HISTORY RECORD (DHR) 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

    IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, PATIENT WAS REVISED DUE UNKNOWN REASONS.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT: UNKNOWN ZIMMER BEARING, CATALOG #:NI, LOT #: NI. IT IS UNKNOWN WHETHER THE PRODUCT WILL BE RETURNING. 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: 0001822565-2018-03566. 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 PATIENT UNDERWENT RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, PATIENT WAS REVISED DUE TO DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500469 FLUTED STEM MOBILE TIBIAL COMPONENT/PRECOAT FOR CEMENTED PROSTHESIS, HIP JWH ZIMMER BIOMET, INC. N/A 62232801

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R