BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD PS OPEN POR FMRL LT 65

    MDR report key: 19746528 · Received July 15, 2024

    Report

    Report Number
    0001825034-2024-01841
    Event Type
    Injury
    Date Received
    July 15, 2024
    Date of Event
    March 3, 2014
    Report Date
    December 23, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K113550
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10 MEDICAL DEVICES: VNGD PS TIB BRG 10X71/75MM CATALOG#: 183640 LOT#: NI. BIOMET CC CRUCIATE TRAY 71MM CATALOG#: 141233 LOT#: NI. PALACOS BONE CEMENT CATALOG#: 66017747 LOT#: NI. G2 FOREIGN SOURCE: NETHERLANDS. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT REMAINS IMPLANTED. 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. UPDATED: B4, B5, B7, D4, D10, G3, G6, H2, H4, H6, AND H11. D10 MEDICAL DEVICES: VNGD PS TIB BRG 10X71/75MM CATALOG#: 183640 LOT#: 2075984. BIOMET CC CRUCIATE TRAY 71MM CATALOG#: 141233 LOT#: 721920. PALACOS BONE CEMENT CATALOG#: 66017747 LOT#: 70411232.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: B4, G3, G6, H2, H3, H6, AND H11. DISEASE PROGRESSION OF OSTEOARTHRITIS CAN CONTINUE IN NATIVE BONE STRUCTURES AS A PATIENT CONTINUES TO AGE. OTHER PATIENT COMORBIDITIES, LIFESTYLE, PHYSICAL ACTIVITIES AND SOME MEDICATIONS CAN INCREASE THE PATIENT¿S RISK FOR PROGRESSIVE OSTEOARTHRITIS. ADDITIONALLY, FEMALES HAVE AN INHERENT RISK. PATIENTS WITH DISEASE PROGRESSION OF OSTEOARTHRITIS IN THE AFFECTED JOINT DEVELOP KNEE PAIN AND DECREASE IN JOINT FLEXIBILITY. AS OSTEOARTHRITIS PROGRESSES A LOSS OF CARTILAGE IN THE PREVIOUSLY UNAFFECTED AREA OF THE KNEE HAS DETERIORATED TO A POINT IN WHICH THE PATIENT AND DOCTOR MAY ELECT TO TAKE AN APPROACH TO RESURFACE THE NATIVE PATELLA TO ALLEVIATE SYMPTOMS. EXCHANGE OF THE POLYETHYLENE LINER IS A STANDARD PROCEDURE WITH RESURFACING OF THE PATELLA WITHOUT ALLEGATIONS AGAINST PRIOR TO THE EXCHANGE.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA STUDY THAT A PATIENT UNDERWENT A LEFT KNEE PATELLA RESURFACING APPROXIMATELY FOUR YEARS POST-IMPLANTATION DUE TO PATELLAR PAIN. THE NATURAL PATELLA WAS REPLACED WITH A PROSTHESIS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY WHERE SURGEON ELECTED NOT TO PLACE A PATELLA COMPONENT. SUBSEQUENTLY, DUE TO POLYTRAUMA OF THE LOWER EXTREMITIES AND ONGOING DISEASE PROGRESSION, THE PATIENT BEGAN EXPERIENCING PAIN AND REQUIRED PLACEMENT OF A PATELLA PROSTHESIS APPROXIMATELY FOUR YEARS FROM THE INITIAL PROCEDURE.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2523781 VANGUARD PS OPEN POR FMRL LT 65 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 133540

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention| H SEE H11.| SEE H11.