BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD CR ILOK FEM-RT 57.5

    MDR report key: 11699313 · Received April 21, 2021

    Report

    Report Number
    0001825034-2021-01142
    Event Type
    Injury
    Date Received
    April 21, 2021
    Date of Event
    March 1, 2017
    Report Date
    June 4, 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
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 141231 - BIOMET CC CRUCIATE TRAY 63MM - J3335544 184780 - SERIES A PAT THN 25 3 PEG - 072250 183422 - VNGD CR TIB BRG 12X63/67 - 909490 402282 - COBALT HV BONE CEMENT 40G - 510390 UNKNOWN - UNKNOWN FEMORAL SCREW - UNKNOWN - UNKNOWN TIBIAL SCREW - UNKNOWN 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. 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. PRIMARY OPERATIVE NOTES STATE NO INTRA OPERATIVE COMPLICATIONS. OFFICE NOTES SHOW THAT THE PATIENT DEVELOPED PAIN, X-RAYS SHOWED OSTEOLYSIS AROUND THE IMPLANTS. REVISION OPERATIVE NOTES STATE THAT FEMORAL COMPONENT WAS REMOVED EASILY, TIBIA WHICH ONLY HAD A LITTLE BIT OF NEED FOR USE OF A FLEXIBLE OSTEOTOME TO BREAK THE BOND OF THE CEMENT AROUND THE CORTICAL RIM AND REMAINDER POPPED OUT WITH EASE. FIBROUS TISSUE AROUND IMPLANTS REMOVED. PATELLAR BUTTON HAD SIGNS OF OSTEOLYSIS UNDERNEATH AND WAS REMOVED EASILY. NO COMPLICATIONS NOTED WITH THIS PROCEDURE. OSTEOLYSIS WAS REPORTED ALONG THE IMPLANTS, HOWEVER A 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2021-01719. 0001825034-2021-01141-2.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: UNKNOWN - UNKNOWN POLY TIBIAL BASEPLATE - UNKNOWN. UNKNOWN - UNKNOWN POLY PATELLA - UNKNOWN. 183422 - VNGD CR TIB BRG 12X63/67 - 510390. 402282 - COBALT HV BONE CEMENT 40G - 510390. UNKNOWN - UNKNOWN FEMORAL SCREW - UNKNOWN. UNKNOWN - UNKNOWN TIBIAL SCREW - UNKNOWN. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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: 0001825034-2021-01141.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY THE PATIENT WAS REVISED APPROXIMATELY 2.5 YEARS LATER DUE TO PAIN AND LOOSENING. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597471 VANGUARD CR ILOK FEM-RT 57.5 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 524760

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| R SEE H10| SEE H10.