BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN NEXGEN FEMORAL

    MDR report key: 6962807 · Received October 19, 2017

    Report

    Report Number
    0001822565-2017-07206
    Event Type
    Injury
    Date Received
    October 19, 2017
    Date of Event
    February 4, 2017
    Report Date
    November 7, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: UNKNOWN NEXGEN TIBIAL TRAY, CAT#: UNKNOWN LOT#: UNKNOWN. UNKNOWN NEXGEN BEARING, CAT#: UNKNOWN LOT#: UNKNOWN. INITIAL REPORTER: YOUNG-HOO KIM, JANG-WON PARK, JUN-SHIK KIM ¿DO HIGH-FLEXION TOTAL KNEE DESIGNS INCREASE THE RISK OF FEMORAL COMPONENT LOOSENING¿ THE JOURNAL OF ARTHROPLASTY 32 (2017) 1862-1868. (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS PRODUCT LOCATION IS UNKNOWN. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. A DEVICE HISTORY RECORD 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 AS THE PART AND LOT NUMBERS ARE UNKNOWN. A ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT 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. PRODUCT LOCATION UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4). THE FOLLOWING REPORT IS SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE REPORTED EVENT WAS CONFIRMED BASED ON X-RAYS PROVIDED IN THE JOURNAL ARTICLE. NO PRODUCTS WERE RETURNED; THEREFORE, THE VISUAL AND DIMENSIONAL INSPECTIONS WERE NOT PERFORMED. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. X-RAY REVIEW PROVIDED IN THE ARTICLE INDICATES THAT ANTEROPOSTERIOR RADIOGRAPH OF BOTH KNEES 10 YEARS AFTER SURGERY, DEMONSTRATING THE NEXGEN HIGH-FLEX TOTAL KNEE PROSTHESIS (RIGHT KNEE, LEFT SIDE OF THE FIGURE) AND NEXGEN STANDARD TOTAL KNEE PROSTHESIS APPEARS TO BE WELL FIXED IN A SATISFACTORY POSITION. LATERAL RADIOGRAPH OF BOTH KNEES 10 YEARS AFTER SURGERY, DEMONSTRATING THAT THE NEXGEN HIGH-FLEX TOTAL KNEE PROSTHESIS (RIGHT KNEE, LEFT SIDE OF THE FIGURE) IS FIXED IN A SATISFACTORY POSITION WITH LESS THAN 1 MM RADIOLUCENT LINE IN PARTIAL PART OF POSTERIOR FEMORAL CONDYLE. HOWEVER, THE NEXGEN STANDARD TOTAL KNEE PROSTHESIS (LEFT KNEE, RIGHT SIDE OF THE FIGURE) APPEARS TO BE FIXED IN A SATISFACTORY POSITION, BUT RADIOLUCENT LINE WIDER THAN 2 MM BETWEEN THE ENTIRE POSTERIOR FEMORAL CONDYLE AND BONE, SUSPECTING FEMORAL COMPONENT LOOSENING WITH PAIN IN THE LEFT KNEE JOINT. ANTEROPOSTERIOR AND LATERAL RADIOGRAPHS OF LEFT KNEE 10 YEARS AFTER REVISION SURGERY DEMONSTRATING THAT FEMORAL COMPONENT IS WELL EMBEDDED IN A SATISFACTORY POSITION WITHOUT RADIOLUCENT LINE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT A PATIENT'S KNEE SHOWED A RADIOLUCENCY LINE IN THE XRAY, INDICATING POSSIBLE LOOSENING WITH ASSOCIATED PAIN OF THE FEMORAL COMPONENT. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741510 UNKNOWN NEXGEN FEMORAL PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other