BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STAGEONE KNEE CEMENT SPACER MOLD TIBIAL COMPONENT

    MDR report key: 6905997 · Received September 29, 2017

    Report

    Report Number
    0001825034-2017-07331
    Event Type
    Injury
    Date Received
    September 29, 2017
    Date of Event
    August 1, 2013
    Report Date
    September 28, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ARTICLE PUBLISHED - UNKNOWN DATE, AUGUST 2013. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN STAGEONE CEMENT SPACER MOLD FEMORAL, CAT#: UNKNOWN LOT#: UNKNOWN . BERNARD STRUELENS, STEVEN CLAES, JOHAN BELLEMANS, ¿SPACER-RELATED PROBLEMS IN TWO-STAGE REVISION KNEE ARTHROPLASTY¿ ACTA ORTHOP. BELG., 2013, 79, 422-426 . THE REPORTED EVENT COULD NOT BE CONFIRMED BASED ON LIMITED INFORMATION RECEIVED. NO PRODUCTS WERE RETURNED; THEREFORE, THE VISUAL INSPECTION 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. A COMPLAINT HISTORY REVIEW WAS UNABLE TO BE PERFORMED. COMPATIBILITY CHECK WAS NOT PERFORMED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. 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 REPORT: 01825034-2017-07330. PRODUCT LOCATION IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT FOUR PATIENTS EXPERIENCED DISLOCATION OF THE FEMORAL OR TIBIAL COMPONENT, FOLLOWING IMPLANTATION OF CEMENT SPACER MOLDS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686010 UNKNOWN STAGEONE KNEE CEMENT SPACER MOLD TIBIAL COMPONENT PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention