BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS POROUS IM STEM

    MDR report key: 18993064 · Received March 28, 2024

    Report

    Report Number
    0001825034-2024-00837
    Event Type
    Injury
    Date Received
    March 28, 2024
    Date of Event
    March 5, 2024
    Report Date
    July 23, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    UDI-DI
    00880304239098
    PMA / PMN Number
    K002757
    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. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H1, H2, H3, H6, H11. CORRECTION: H6. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS PROVIDED. VISUAL EXAMINATION OF THE RETURNED PRODUCT FOUND THAT IT SHOWS SIGNS OF BEING IMPLANTED DISCOLORATIN/ 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - MEDICAL PRODUCT: OSS 7CM SEGMENTAL FEMORAL RT CATALOG # 150354 LOT # 542380 OSS POR STRAIGHT STEM 16.5X150 CATALOG # 150451 LOT # 183380 OSS 4CM DIAPHYSEAL SEGMENT CATALOG # 150482 LOT # 899890R 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 THE COMPLAINT DEVICE HAS BEEN RETURNED, BUT THE DEVICE INVESTIGATION HAS NOT YET BEEN COMPLETED. ONCE THE EVALUATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    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 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
    720516 OSS POROUS IM STEM PROSTHESIS KNEE KRO ZIMMER BIOMET, INC. N/A 414120 00880304239098

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R