BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNGD CR TIB BRG 18X79/83

    MDR report key: 18640916 · Received February 5, 2024

    Report

    Report Number
    0001825034-2024-00299
    Event Type
    Injury
    Date Received
    February 5, 2024
    Date of Event
    January 15, 2024
    Report Date
    July 18, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HRY
    PMA / PMN Number
    K023546
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. ADDITIONAL ASSOCIATED PRODUCTS & MDRS. 183073 VANGUARD CR POR FMRL-LT 72.5 LOT# 454790. MDR: 0001825034-2024-00298. ADDITIONAL ASSOCIATED PRODUCTS. 185290 VNGD SSK 360 L FEM 80MM LOT# 6495422. 148328 BMT SPLINED KNEE STM V2 14X160 LOT# 400340. 185410 VG 360 DST FM AG 80X10 LL/RM LOT# 082110. 185390 VG 360 DST FM AG 80X10 RL/LM LOT# 606040.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED. VISUAL EVALUATION OF THE PROVIDED PHOTOS FOUND EVIDENCE OF USE (SURGICAL DEBRIS); HOWEVER, NO FURTHER INFORMATION CAN BE DETERMINED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THE REPORTED PART AND LOT COMBINATIONS. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: COMPONENTS ARE ANATOMICALLY ALIGNED; RADIOLUCENCY ALONG FEMORAL AND TO A LESSER DEGREE AROUND TIBIAL AND PATELLA COMPONENTS; OSTEOLYSIS; POSSIBLE LOOSENING BUT NOT CONFIRMED. THIS COMPLAINT CANNOT BE CONFIRMED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. NO ACTIONS NEEDED AT THIS TIME. THIS COMPLAINT WAS DETERMINED NOT TO BE A NEW CONFIRMED QUALITY OR MANUFACTURING ISSUE. COMPLAINTS ARE MONITORED THROUGH MONTHLY COMPLAINT REVIEW (REFERENCE (B)(4)) IN ORDER TO IDENTIFY POTENTIAL ADVERSE TRENDS. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT WAS REVISED FOR PAIN, EFFUSION, AND SUSPECTED IMPLANT LOOSENING, AS RADIOLUCENCY WAS NOTED AROUND THE FEMORAL COMPONENT. THE FEMORAL IMPLANT AND ARTICULAR SURFACE WERE REVISED.

    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
    287891 VNGD CR TIB BRG 18X79/83 PROSTHESIS, KNEE HRY ZIMMER BIOMET, INC. N/A 019770

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R