BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED

    MDR report key: 14026512 · Received April 6, 2022

    Report

    Report Number
    3007963827-2022-00085
    Event Type
    Malfunction
    Date Received
    April 6, 2022
    Date of Event
    March 22, 2022
    Report Date
    April 6, 2022
    Manufacturer
    ZIMMER ORTHOPAEDIC MFG. LTD.
    Product Code
    JWH
    UDI-DI
    00889024641181
    PMA / PMN Number
    K113369
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 42540000029, ALL POLY PATELLA CEMENTED 29 MM DIAMETER, 65270883. 42532006401, TIBIA CEMENTED 5 DEGREE STEMMED LEFT SIZE C, 65204292. 42500606001, FEMUR CEMENTED POSTERIOR STABILIZED (PS) STANDARD LEFT SIZE 6, 64921989. 98-0002-400-00, PSN CM FM/CM TB/PE/PE PSN PT, UNKNOWN. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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 · 0

    IT WAS REPORTED THAT THE POLY DID NOT SEAT PROPERLY ON THE TIBIAL PLATE. THE SURGICAL TECHNIQUE WAS UTILIZED. THERE WAS NO SURGICAL DELAY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2403056 ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED PROSTHESIS, KNEE JWH ZIMMER ORTHOPAEDIC MFG. LTD. N/A 64684051 00889024641181

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose