BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM EXTENSION

    MDR report key: 16636310 · Received March 29, 2023

    Report

    Report Number
    0002648920-2023-00047
    Event Type
    Injury
    Date Received
    March 29, 2023
    Date of Event
    February 1, 2023
    Report Date
    March 14, 2023
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JWH
    UDI-DI
    00889024221147
    PMA / PMN Number
    K173057
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MEDICAL PRODUCT: FEMORAL COMPONENT OPTION FOR CEMENTED USE CATALOG # 00599401391 LOT # 64012476. STEMMED TIBIAL COMPONENT CATALOG # 00598800300, LOT # 64678309. HEADLESS TROCAR DRILL PIN 3.2 MM DIAMETER 75 MM LENGTH CATALOG # 00590102000 LOT # 64809158 ARTICULAR SURFACE WITH LOCKING SCREW SIZE YELLOW/C,D 17 MM HEIGHT FOR USE WITH FEMORAL C,D CATALOG # 00599403017 LOT # 64614539. TWO DEVICE IDS WERE PROVIDED BY THE REPORTER; OF THESE, ONLY ONE (1) WAS REPORTED FOR LOOSENING. IT IS UNKNOWN WHICH EXACT DEVICE ENCOUNTERED THIS ISSUE, IT IS ONE OF THE FOLLOWING: CATALOG # 00598801215, LOT # 64036688. MANUFACTURE DATE: JUN 1, 2018. STERILE EXPIRY DATE: MAY 31, 2028. UDI #: (B)(4). 510K: K173057. PRO CODE: JWH. OR CATALOG # 00598801215 LOT # 65133553. MANUFACTURE DATE: AUG 20, 2021. STERILE EXPIRY DATE: JUL 13, 2031. UDI #: (B)(4). 510K: K173057. PRO CODE: JWH. REPORT SOURCE: AUSTRALIA. SUGGESTED COMPONENT CODE: MECHANICAL (G04) - STEM. MULTIPLE MDR REPORTS WERE FILLED FOR THIS EVENT: 0001822565-2023-00474, 0001822565-2023-00473. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE WAS NOT RETURNED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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

    IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE ONE YEARS POST IMPLANTATION DUE TO LOOSENING OF FEMUR AND TIBIAL PROSTHESIS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    975830 STEM EXTENSION PROSTHESIS KNEE JWH ZIMMER MANUFACTURING B.V. N/A 64036688 00889024221147

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R