BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS 3CM ELLIP DIAPHYSEAL SEG

    MDR report key: 18397118 · Received December 27, 2023

    Report

    Report Number
    0001825034-2023-03041
    Event Type
    Injury
    Date Received
    December 27, 2023
    Date of Event
    December 7, 2023
    Report Date
    February 19, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    UDI-DI
    00880304239821
    PMA / PMN Number
    K123501
    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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 150354 - OSS 7CM SEGMENTAL FEMORAL RT - 705420; 150366 - OSS CEMENTED IM STEM 12X150 - 268820; 00223200418 - CABLE CERCLAGE CABLE WITH CRIMP 1.8 MM DIA. 635 MM LENGTH - 64957282; 184784 - SERIES A PAT THN 31 3 PEG - 339190; 161043 - OSS NON-MOD TIB PLATE LONG 71 - 658840; 150410 - OSS TIBIAL POLY BEARING 12MM - 050800; 150476 - OSS POLY TIBIAL BUSHING - 173220; 150493 - OSS REINFORCED YOKE - 688150; 150477 - OSS POLY FEMORAL BUSHINGS - 330920; 150478 - OSS POLY LOCK PIN - 025020; 150480 - OSS AXLE - 911840. G2 : FOREIGN COUNTRY : AUSTRALIA. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT WAS DISCARDED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2023-03040; 0001825034-2023-03042.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL KNEE PROCEDURE. APPROXIMATELY 2.5 YEARS POST-OP, THE PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMUR AFTER A SOFT TISSUE INJURY. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1299609 OSS 3CM ELLIP DIAPHYSEAL SEG PROSTHESIS, KNEE JDI ZIMMER BIOMET, INC. N/A 187630 00880304239821

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Hospitalization| R