BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VAN PS OPEN INTL FEM-RT 67.5

    MDR report key: 11685314 · Received April 19, 2021

    Report

    Report Number
    0001825034-2021-01120
    Event Type
    Injury
    Date Received
    April 19, 2021
    Date of Event
    February 21, 2018
    Report Date
    April 28, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K113550
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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 RADIOGRAPHIC FINDINGS OF SEPTIC LOOSENING OF RIGHT KNEE WITH RIGHT KNEE INSTABILITY AND SEVERE RIGHT KNEE PAIN. POLY WAS REMOVED WITH BACKSIDE WEAR NOTED. EXTENSIVE SCAR TISSUE AROUND THE FEMUR, REMOVED COMPONENT AND ENTIRE CEMENT MANTLE WITH NO BONE LOSS, CEMENT ALSO CAME OFF QUITE EASILY FROM THE IMPLANT. TIBIAL IMPLANT REMOVED WITHOUT DIFFICULTY. 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: 141225 - TIBIAL TRAY - J3490244; 183662 - BEARING - 630420; 402283 - COBALT BONE CEMENT - 437600; 184768 - PATELLA - 996200. 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: 0001825034-2021-01121, 0001825034-2021-01122.

    Description of Event or Problem · 1

    IT WAS REPORTED BY LEGAL THAT A PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION DUE TO ASEPTIC LOOSENING, INSTABILITY, AND SEVERE PAIN APPROXIMATELY 3 YEARS POST IMPLANTATION. INTRAOPERATIVELY, SCAR TISSUE, BACK SIDE POLY WEAR, AND EASILY REMOVED IMPLANTS & CEMENT WERE ENCOUNTERED. THE FEMORAL COMPONENT, TIBIAL COMPONENT, AND BEARING WERE REMOVED AND COMPETITOR PRODUCT PLACED. OP NOTES STATE THAT THE PATELLA WAS STABLE AND DID NOT NEED TO BE REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585819 VAN PS OPEN INTL FEM-RT 67.5 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 008300

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R