BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN ARTICULAR SURFACE

    MDR report key: 7854740 · Received September 7, 2018

    Report

    Report Number
    0001822565-2018-04890
    Event Type
    Injury
    Date Received
    September 7, 2018
    Date of Event
    March 3, 2018
    Report Date
    March 12, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK933785
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REVIEW OF ADDITIONAL INFORMATION RECEIVED FROM THE CLINICAL STUDY MANAGER, REVEALS THE PATIENT WAS SUSPECTED TO HAVE AN INFECTION POST PROCEDURE, DUE TO ELEVATED CPK LEVELS. IT WAS UNSURE WHY THE PATIENT EXPERIENCED ELEVATED CPK LEVELS, AND WAS TREATED WITH ANTIBIOTICS PROACTIVELY. AS FURTHER TESTING WAS CONDUCTED NO INFECTION OR SOURCE OF INFECTION WAS FOUND, AND CPK LEVEL RETURNED TO NORMAL. CPK LEVELS CAN BE ELEVATED FOR MANY REASONS, INCLUDING RECENT SURGICAL PROCEDURES. AS THERE WAS NO IDENTIFIED OR CONFIRMED POST PROCEDURE INFECTION, THIS WAS DETERMINED TO BE NOT REPORTABLE.

    Description of Event or Problem · 0

    UPON REVIEW OF ADDITIONAL INFORMATION RECEIVED FROM THE CLINICAL STUDY MANAGER, REVEALS THE PATIENT WAS SUSPECTED TO HAVE AN INFECTION POST PROCEDURE, DUE TO ELEVATED CPK LEVELS. IT WAS UNSURE WHY THE PATIENT EXPERIENCED ELEVATED CPK LEVELS, AND WAS TREATED WITH ANTIBIOTICS PROACTIVELY. AS FURTHER TESTING WAS CONDUCTED NO INFECTION OR SOURCE OF INFECTION WAS FOUND, AND CPK LEVEL RETURNED TO NORMAL. CPK LEVELS CAN BE ELEVATED FOR MANY REASONS, INCLUDING RECENT SURGICAL PROCEDURES. AS THERE WAS NO IDENTIFIED OR CONFIRMED POST PROCEDURE INFECTION, THIS WAS DETERMINED TO BE NOT REPORTABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL CONCOMITANT MEDICAL PRODUCTS: NEXGEN CR-FLEX FEMORAL COMPONENT, CATALOG # 00575201502, LOT # 63583982; NEXGEN STEMMED TIBIAL COMPONENT, CATALOG # 00598603702, LOT # 63851973; NEXGEN ALL POLY PATELLA, CATALOG # 00597206532, LOT # 63841081. (B)(6). OUR INVESTIGATION IS ONGOING. A FOLLOW-UP/FINAL REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2018-04891, 0002648920-2018-00681, 0002648920-2018-00682. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY, A FEW DAYS LATER, THE PATIENT STARTED TO EXPERIENCES UNKNOWN COMPLICATIONS. THESE COMPLICATIONS RESULTED IN AN ANTIBIOTIC TREATMENT. THE PATIENT ALSO EXPERIENCED STOMACH PAIN. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698859 NEXGEN ARTICULAR SURFACE PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. NI 63786789

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R