BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS ELLIP DIAPHYSEAL SEG

    MDR report key: 19805082 · Received July 23, 2024

    Report

    Report Number
    0001825034-2024-01888
    Event Type
    Injury
    Date Received
    July 23, 2024
    Date of Event
    March 5, 2024
    Report Date
    July 23, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    UDI-DI
    00880304239821
    PMA / PMN Number
    K123501
    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). D10 - MEDICAL PRODUCT: OSS POROUS IM STEM CATALOG # 150381 LOT # 414120; OSS 7CM SEGMENTAL FEMORAL RT CATALOG # 150354 LOT # 542380; OSS 4CM DIAPHYSEAL SEGMENT CATALOG # 150482 LOT # 899890; OSS NON-MOD TIB PLATE LONG 63 CATALOG # 150419 LOT # 443540; OSS TIBIAL POLY BEARING 14MM CATALOG # 150411 LOT # 063740; ALLEN MEDULLARY CEMENT PLUGS 1-16 MM DIAMETER FLANGE/8 MM DIAMETER CORE STORE IN COOL DRY PLACE CATALOG # 00801102016 LOT # 64325372. G2: AUSTRALIA. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS PROVIDED. VISUAL EXAMINATION OF THE RETURNED PRODUCT FOUND THAT IT SHOWS SIGNS OF BEING IMPLANTED DISCOLORATION / FOREIGN MATERIAL AND EXPLANTED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. X-RAY REVIEW INDICATES THERE IS EXTENSIVE RADIOLUCENCY ALONG THE FEMORAL IMPLANT WHICH IS LOOSE AS NOTED. OVERALL ALIGNMENT OF THE RIGHT KNEE ARTHROPLASTY IS MAINTAINED 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 YEAR POST IMPLANTATION DUE TO LOOSENING OF IMPLANT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    963818 OSS ELLIP DIAPHYSEAL SEG PROSTHESIS KNEE JDI ZIMMER BIOMET, INC. N/A 183380 00880304239821

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R SEE H10 NARRATIVE.