BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD CR ILOK FEM-RT 65

    MDR report key: 11463706 · Received March 11, 2021

    Report

    Report Number
    0001825034-2021-00729
    Event Type
    Injury
    Date Received
    March 11, 2021
    Date of Event
    October 8, 2020
    Report Date
    July 15, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K023546
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. HOSPITAL NOTES WERE PROVIDED AND REVIEWED BY A HEALTHCARE PROFESSIONAL. REVIEW FOUND THE 7 YEAR FOLLOW UP SHOWS THE PATIENT IS EXPERIENCING NO PAIN AND IS EXPERIENCING NO DIFFICULTIES WITH MOBILITY. AT THIS FOLLOW UP, THE PROSTHESIS APPEARS TO BE OPTIMALLY SIZED WITHOUT MIGRATION. FURTHER MEDICAL RECORDS WERE NOT PROVIDED. X-RAYS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW FOUND RIGHT TOTAL KNEE ARTHROPLASTY WITH POSSIBLE POLYETHYLENE WEAR OF THE MEDIAL COMPARTMENT WITH ASSOCIATED GENU VARUS DEFORMITY AND POSSIBLE TIBIAL COMPONENT FRACTURE MEDIALLY. OVERALL SIZE OF THE IMPLANT IS APPROPRIATE. NORMAL BONE MINERALIZATION. NO SIGNS OF LOOSENING, RADIOLUCENCY. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED.

    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: 183420 1926429 VNGD CR TIB BRG 10X63/67; 141232 358010 BIOMET CC CRUCIATE TRAY 67MM; 184720 394140 SERIES A PAT W/WR THN 25 1 PEG. FOREIGN COUNTRY: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DUE TO THE LOCATION OF THE DEVICE 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 - 00728, 0001825034 - 2021 - 00730.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED ON AN UNKNOWN DATE DUE TO RECURRENT DISLOCATIONS AND INSTABILITY CAUSED BY POLY WEAR DUE TO DEVICE MALPOSITION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358533 VANGUARD CR ILOK FEM-RT 65 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 2063104

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10 NARRATIVE.