BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET CC CRUCIATE TRAY 71MM

    MDR report key: 13415814 · Received February 1, 2022

    Report

    Report Number
    0001825034-2022-00207
    Event Type
    Injury
    Date Received
    February 1, 2022
    Date of Event
    January 4, 2022
    Report Date
    June 16, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K171054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: VANGUARD CR POR FEM-RT 65: CATALOG#183048, LOT#478080; VNGD CR TIB BRG 10X71/75 MM: CATALOG#183440, LOT#339810; BMET ARCOM AP PAT W/WIRE 28MM: CATALOG#11-150825, LOT#791390. MULTIPLE MDR REPORTS HAVE BEEN FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORTS: 0001825034-2022-00205; 0001825034-2022-00206; 0001825034-2022-00208. CUSTOMER HAS INDICATED THAT 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; G3; H2; H10. UPON REASSESSMENT OF THE REPORTED EVENT, THIS DEVICE WAS DETERMINED TO BE NOT REPORTABLE. THE ATTRIBUTABLE MALFUNCTIONS OF THIS DEVICE SUCH AS LOOSENING ARE DUE TO OSTEOLYSIS CAUSED BY WEAR OF THE POLYETHYLENE COMPONENTS. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY EIGHT YEARS AND THREE MONTHS POST IMPLANTATION, THE PATIENT WAS REVISED DUE TO PAIN, SWELLING, LIMITED MOBILITY, POLYETHYLENE INSERT WEAR, PATELLAR IMPLANT MIGRATION, AND OSTEOLYSIS OF THE TIBIA, PATELLA, AND FEMUR. DURING THE PROCEDURE, ASEPTIC LOOSENING OF THE TIBIAL AND PATELLAR COMPONENTS, SEVERE SYNOVITIS, TIBIAL ANTERIOR RADIOLUCENCY, AND EROSION OF THE FEMUR WERE NOTED. THE TIBIAL TRAY, TIBIAL BEARING, AND PATELLAR COMPONENT WERE REVISED. UPON FOLLOW-UP, THE PATIENT WAS SATISFIED WITH RESTORED RANGE OF MOTION AND MINIMAL PAIN.

    Description of Event or Problem · 0

    SEE H10 NARRATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504227 BIOMET CC CRUCIATE TRAY 71MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. J3099415

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| H SEE H10 NARRATIVE.