BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET CRUCIATE TIBIAL TRAY

    MDR report key: 7136305 · Received December 20, 2017

    Report

    Report Number
    0001825034-2017-11349
    Event Type
    Injury
    Date Received
    December 20, 2017
    Date of Event
    December 4, 2017
    Report Date
    September 17, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK171054
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE PRODUCT WAS RETURNED AND FROM VISUAL INSPECTION THE TIBIAL TRAY SHOWS SCRATCHES AND DEFORMITY. THERE WAS NOT BONE CEMENT PRESENT. 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). REPORTED EVENT WAS CONFIRMED AS PROVIDED PHOTOS SHOW NO BONE CEMENT ADHERENCE. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. PRODUCTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. EXTERNAL RADIOLOGIST REVIEWED PROVIDED X-RAYS AND NOTED NORMAL ANATOMY, HOWEVER, BONE QUALITY AND POSSIBLE LUCENCY IS DIFFICULT TO ASSESS DUE TO POOR QUALITY OF THE IMAGES. 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). DATE OF BIRTH: PATIENT WAS BORN IN (B)(6). CONCOMITANT MEDICAL PRODUCTS: VANGUARD ILOK FEMORAL, CATALOG #: 183006 LOT #: J3757577, VANGUARD TIBIAL BEARING, CATALOG #: 183420 LOT #: 060850, HI-FATIGUE BONE CEMENT, CATALOG #: 00112124001 LOT #: 14KA18491, SERIES-A PATELLA, CATALOG #: 184784 LOT #: 242760. REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT KNEE REVISION ARTHROPLASTY DUE TO LACK OF BONDING BETWEEN THE TIBIAL COMPONENT AND BONE CEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED TO ADDRESS TIBIAL LOOSENING. LOOSENING OCCURRED BETWEEN THE IMPLANT AND CEMENT INTERFACE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914154 BIOMET CRUCIATE TIBIAL TRAY PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A J3734232

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R