BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN ARTICULAR SURFACE ANTERIOR CONSTRAINED

    MDR report key: 7467871 · Received April 27, 2018

    Report

    Report Number
    0001822565-2018-02316
    Event Type
    Injury
    Date Received
    April 27, 2018
    Date of Event
    March 1, 2018
    Report Date
    August 2, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK933785
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: TIBIAL COMPONENT STEMMED CATALOG 00598003701, LOT 63316226 UNKNOWN FEMORAL COMPONENT. EXAMINATION OF THE RETURNED DEVICE CONFIRMS THE REPORTED IMPLANT DISLOCATION IN-VIVO. KNICKS AND GOUGES ON THE INFERIOR SIDE AS WELL AS INFERIOR LATERAL SIDE DAMAGE WERE IDENTIFIED. THE DIMENSIONS WERE FOUND TO BE CONFORMING WHERE MEASURED. REVIEW OF DEVICE HISTORY RECORDS IDENTIFIED NO RELATED DEVIATIONS OR ANOMALIES. PER PACKAGE INSERT NEXGEN CR, PS, CRA, LPS AND LCCK KNEE (87-6203-453-23 REV. D), DISLOCATION IS ONE OF THE KNOWN ADVERSE EFFECT OF THE TKA PROCEDURE. HOWEVER, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT: NEXGEN PRECOAT STEMMED TIBIAL COMPONENT CATALOG # 00598003701 LOT # 63316226. STEM EXTENSION STRAIGHT 12 MM DIA X 100 MM LENGTH(COMBINED LENGTH 145 MM) CATALOG # 00598801012 LOT # 63682213 TIBIAL COMPONENT STEMMED PRECOAT USE OF THIS TIBIAL COMPONENT WITH LEGACY KNEE - CONSTRAINED CONDYLAR KNEE (LCCK) ARTICULATING SURFACES REQUIRES USING CATALOG # 00598003701 LOT # 63600569. THE COMPLAINT DEVICE HAS BEEN RETURNED, BUT THE DEVICE INVESTIGATION HAS NOT YET BEEN COMPLETED. ONCE THE EVALUATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILLED FOR THIS EVENT: 0002648920-2018-00338.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO DISLOCATION OF ARTICULATING COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310539 NEXGEN ARTICULAR SURFACE ANTERIOR CONSTRAINED KNEE PROSTHESIS JWH ZIMMER BIOMET, INC. N/A 63707641

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R