BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET CC I-BEAM TRAY 75MM

    MDR report key: 11700708 · Received April 21, 2021

    Report

    Report Number
    0001825034-2021-01192
    Event Type
    Injury
    Date Received
    April 21, 2021
    Date of Event
    May 15, 2017
    Report Date
    April 27, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K142933
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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 PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW FOUND RIGHT KNEE PAIN AND INSTABILITY. IMAGING REVEALED LOOSENING. OSTEOTOMES USED TO BREAK CEMENT MANTLE AROUND FEMUR AND TIBIA. PATELLA WELL-FIXED AND RETAINED. NO COMPLICATIONS NOTED. 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 DEVICES: 183053 - FEMORAL COMPONENT - 813000; 183440 - BEARING - 447810; 402283 - COBALT BONE CEMENT - 859930. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. 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: 0001825034-2021-01190, 0001825034-2021-01191.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT PRIMARY RIGHT TKA. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO PAIN, LOOSENING AND INSTABILITY APPROXIMATELY 2 YEARS POST IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597908 BIOMET CC I-BEAM TRAY 75MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A J3252931

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R