BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIA FIXED CEMENTED LEFT SIZE F STEM EXTENSION USE REQUIRED

    MDR report key: 11327375 · Received February 15, 2021

    Report

    Report Number
    0001822565-2021-00400
    Event Type
    Injury
    Date Received
    February 15, 2021
    Date of Event
    October 7, 2020
    Report Date
    February 12, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00889024562806
    PMA / PMN Number
    K191625
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS : TEM#: 42512100710; ARTICULAR SURFACE MEDIAL CONGRUENT (MC) LEFT 10 MM HEIGHT USE WITH TIBIA SIZES E-F/CR FEMUR SIZES 6-7; LOT#: 64666577. REPORT SOURCE: FOREIGN : (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3007963827-2020-00287. REPORTED EVENT WAS CONFIRMED BY EVALUATION OF RETURNED ASSOCIATED DEVICE, AS THIS DEVICE WAS NOT RETURNED AS IT REMAINS IMPLANTED IN THE PATIENT.. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. PER PERSONA REVISION KNEE SYSTEM IFU, IT IS STATED DO NOT USE THE PERSONA REVISION FEMORAL COMPONENTS OR TIBIAL PLATES WITH THE PERSONA CRUCIATE RETAINING (CR), MEDIAL CONGRUENT (MC) OR ULTRA CONGRUENT (UC) ARTICULAR SURFACES. DO NOT USE THE PERSONA REVISION CCK ARTICULAR SURFACES WITH THE PERSONA PS OR CR FEMORAL COMPONENTS. THEY ARE NOT DESIGNED TO BE COMPATIBLE. HENCE THE ROOT CAUSE IS ATTRIBUTED TO OFF LABEL USE. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TOTAL KNEE ARTHROPLASTY WAS PERFORMED WITH PERSONA. THE SURGEON COULD NOT INSERT PERSONA MC SURFACE TO TIBIA BASE PLATE AND HE DISENGAGED THE SURFACE TO CLEAN SPACE BETWEEN THE SURFACE AND THE TIBIA BASE PLATE BY SALINE. AFTER THAT, HE TRIED TO INSERT THE SURFACE AGAIN BUT HE COULD NOT. SUBSEQUENTLY, PERSONA UC SURFACE WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225749 TIBIA FIXED CEMENTED LEFT SIZE F STEM EXTENSION USE REQUIRED PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 64495998 00889024562806

    Patients

    Seq Age Sex Outcome Treatment
    1 Other