BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERSONA NATURAL TIBIA CEMENTED 5 DEGREE STEMMED

    MDR report key: 7169856 · Received January 5, 2018

    Report

    Report Number
    0002648920-2018-00015
    Event Type
    Injury
    Date Received
    January 5, 2018
    Date of Event
    June 15, 2015
    Report Date
    January 5, 2018
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JWH
    PMA / PMN Number
    PK122765
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: FEMUR CEMENTED POSTERIOR STABILIZED (PS) STANDARD LEFT SIZE 10 LOT#62747654 ITEM#42500606801, PSN ASF PS 10MM VE L 10-12 GH LOT#62866060 ITEM#42512401010, ALL-POLY PATELLA, VE 38MM X 9.5MM LOT#62916598 ITEM#42540200038, HEADLESS TROCAR DRILL PIN 75MM LOT#62899977 ITEM#00590102000, 48MM HEADED SCREW LOT#62916537 ITEM#00579104100, 48MM HEADED SCREW LOT#62916538 ITEM#00579104100, PSN ASF PS 12MM VE L 10-12 GH LOT#62679125 ITEM#42512401012. THE REPORTED EVENT COULD NOT BE CONFIRMED BASED ON LIMITED INFORMATION RECEIVED. NO PRODUCTS WERE RETURNED; THEREFORE, THE VISUAL AND DIMENSIONAL INSPECTIONS WERE NOT PERFORMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. THE COMPONENTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. 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 REPORTS: 3007963827-2018-00004, 0001822565-2017-04723

    Description of Event or Problem · 1

    IT WAS REPORTED FOLLOWING A LEFT KNEE ARTHROPLASTY, THE PATIENT UNDERWENT A MANIPULATION. THE PATIENT IS EXPERIENCING LOOSENING, SWELLING, POPPING AND SNAPPING. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13381 PERSONA NATURAL TIBIA CEMENTED 5 DEGREE STEMMED PROSTHESIS, KNEE JWH ZIMMER MANUFACTURING B.V. N/A 62954439

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R