BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS CEMENTED IM STEM 17MMX90MM

    MDR report key: 10140451 · Received June 10, 2020

    Report

    Report Number
    0001825034-2020-02319
    Event Type
    Injury
    Date Received
    June 10, 2020
    Date of Event
    May 19, 2020
    Report Date
    August 27, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    UDI-DI
    00880304238923
    PMA / PMN Number
    K123501
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    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 DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. 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.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 150419 - OSS NON-MOD TIB PLATE - 341940. 150476 - OSS POLY TIBIAL BUSHING - 443300. 150477 - OSS POLY FEM BUSHING - 570690. 150493 - OSS REINFORCED YOKE - 972010. 150480 - OSS AXLE - 168970. 150478 - OSS POLY LOCK PIN - 588390. 150350 - OSS 3CM RESURFACING FEMORAL RT - 491030. 150412 - OSS TIBIAL POLY BEARING - 900400. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT IS UNAVAILABLE BY HOSPITAL POLICY. THE INVESTIGATION IS IN PROCESS. 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: 0001825034-2020-02320. 0001825034-2020-02321.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT KNEE REVISION APPROXIMATELY 3.5 YEARS POST IMPLANTATION DUE TO LOOSENING. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600839 OSS CEMENTED IM STEM 17MMX90MM PROSTHESIS, KNEE JDI ZIMMER BIOMET, INC. N/A 613590 00880304238923

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R