BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL COMPONENT STEMMED

    MDR report key: 7644918 · Received June 28, 2018

    Report

    Report Number
    0001822565-2018-03341
    Event Type
    Injury
    Date Received
    June 28, 2018
    Date of Event
    February 7, 2018
    Report Date
    May 6, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK933785
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UDI # (B)(4). ARTICULAR SURFACE CATALOG # 00599403010 LOT # 62131754 AUGMENT BLOCK UNKNOWN STEM EXTENSION UNKNOWN COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. VISUAL EXAMINATION OF CEMENTED STEMMED TIBIA AND ARTICULAR SURFACE EXHIBITS SIGN OF USE (NICKED OR GOUGED). THE AUGMENT BLOCK & STEM EXTENSION REMAIN ASSEMBLED TO THE TIBIA PLATE AND BONE CEMENT REMAINS ON STEM AND BACK OF TIBIAL PLATE TOO. NO FURTHER INVESTIGATION CAN/WILL BE PERFORMED ON STEM EXTENSION AND AUGMENT AS THE PRODUCT IDENTIFICATION ARE UNKNOWN. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. MEDICAL RECORDS WERE NOT PROVIDED. PER PACKAGE INSERT 87-6203-453-23 REV D NEXGEN CR, PS, CRA, LPS AND LCCK KNEE: LOOSENING IS KNOWN ADVERSE EFFECT OF THIS PROCEDURE. 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.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE PRODUCT IS RETURNED THE INVESTIGATION WILL BE COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT KNEE PROCEDURE. THE REVISION SURGERY WAS DUE TO TIBIAL COMPONENT LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487677 TIBIAL COMPONENT STEMMED PROTHESIS KNEE JWH ZIMMER BIOMET, INC. NI 63583663

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R