BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNGD CR TIB BRG 10X71/75 MM

    MDR report key: 13415784 · Received February 1, 2022

    Report

    Report Number
    0001825034-2022-00206
    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; BIOMET CC CRUCIATE TRAY 71MM: CATALOG#141233, LOT#J3099415; 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; 0001825034-2022-00207; 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 HAVE BEEN UPDATED: B4; B5; G3; H2; H3; H6; H10. VISUAL EXAMINATION OF THE PROVIDED PICTURES FOUND EXCESSIVE WEAR OF THE ARTICULAR SURFACE. THE DEVICE WAS NOT RETURNED FOR FURTHER EVALUATION. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW FOUND PATIENT PRESENTED WITH PAIN AND SWELLING. X-RAY REVIEW FOUND DECREASED SPACE BETWEEN THE FEMORAL AND TIBIAL COMPONENTS, RADIOLUCENCY IN THE CEMENT MANTLE INTERFACE BETWEEN THE BONE AND TIBIAL COMPONENT, AND THE PATELLA BUTTON MIGRATED ANTERIORLY SEPARATING FROM THE PATELLA. CT SCAN REVEALED LUCENCY AROUND THE TIBIA, BONE LOSS AT THE ANTERIOR ASPECT OF THE TIBIA BENEATH THE ANTERIOR BASE PLATE, EROSIVE CHANGES OF THE LATERAL FEMORAL CONDYLE, LOOSE PATELLA. DURING THE REVISION PROCEDURE THE SURGEON FOUND OSTEOLYSIS ON THE RIGHT TIBIA AND PATELLA, ASEPTIC LOOSENING OF THE RIGHT TIBIA AND PATELLA, AND SEVERE SYNOVITIS. THE PATELLA HAD THINNING AND A FRACTURE LINE. ROOT CAUSE WAS UNABLE TO 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

    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 TIBIA AND PATELLA, 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

    NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486502 VNGD CR TIB BRG 10X71/75 MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. 339810

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization| R