BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS POROUS IM STEM 17.5 X 90

    MDR report key: 11776737 · Received May 5, 2021

    Report

    Report Number
    0001825034-2021-01387
    Event Type
    Injury
    Date Received
    May 5, 2021
    Date of Event
    April 14, 2021
    Report Date
    June 8, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    UDI-DI
    00880304239166
    PMA / PMN Number
    K123501
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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: 150355 - OSS SEGMENTAL FEMORAL - 188880, 150464 - OSS 3CM DIAPHYSEL SEGMENT - 119830, 150493 - OSS REINFORCED YOKE - 293590, 150477 - OSS POLY FEMORAL BUSHINGS - 869290, 130615 - INTRAMEDULLARY PLUG XL - 372180, 150480 - OSS AXLE - 171210, 150476 - OSS POLY TIBIAL BUSHING - 783180, 150411 - OSS TIBIAL POLY BEARING 14MM - 274210, 150510 - OSS POLY BUMPER LOCK PIN - 747270, 110035368 - BIOMET BC R 1X40 US - 927BAA2502. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT WAS NOT RETURNED BY THE HOSPITAL. 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: 0001825034-2021-01386.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A LEFT KNEE REVISION APPROXIMATELY 10 MONTHS POST IMPLANTATION DUE TO A LOOSE POROUS STEM AND FEMORAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672813 OSS POROUS IM STEM 17.5 X 90 PROSTHESIS, KNEE JDI ZIMMER BIOMET, INC. N/A 427060 00880304239166

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R