BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 VIVACIT-E

    MDR report key: 22183029 · Received June 11, 2025

    Report

    Report Number
    0001822565-2025-01815
    Event Type
    Injury
    Date Received
    June 11, 2025
    Date of Event
    January 2, 2025
    Report Date
    June 11, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024520547
    PMA / PMN Number
    K190660
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CAT: 650-1058, LOT: 3111577, CER BIOLOXD OPTION HD. CAT: 650-1066, LOT: 3111783, CER OPT TYPE 1 TPR SLEVE. CAT: 110010246, LOT: 65273587, G7 OSSEOTI 4 HOLE SHELL. CAT: 51-149080, LOT: 7148678, TPRLC XR MP FP T1 PPS. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS WERE PROVIDED AND REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: PATIENT HAD AN INITIAL THA AND BEGAN EXPERIENCING PAIN AND WEAKNESS WITH RESISTED RIGHT HIP FLEXION SITTING AT 90 DEGREES. BURSITIS AND ILIOPSOAS TENDINITIS NOTED AND RELIEF WITH INJECTION. PAIN ALONG RIGHT GROIN. PATIENT HAD A REVISION DUE TO FAILED IMPLANTS AND SEVERE PAIN. ILIOPSOAS TENOTOMY NOTED. CUP WAS WELL FIXED AND NO LOOSENING OBSERVED. LINER, STEM AND HEAD WERE EXPLANTED. NO OTHER COMPLICATIONS NOTED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED BASED ON THE MEDICAL RECORDS, THE COMPLAINT IS CONFIRMED. 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 THAT APPROXIMATELY TWO YEARS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO SEVERE PAIN AND FAILED IMPLANTS. PATIENT EXPERIENCED PAIN, WEAKNESS, TROCHANTERIC BURSITIS, AND POSSIBLE ILIOPSOAS TENDINITIS. THE SHELL WAS RETAINED AND ALL OTHER IMPLANTS REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70657 G7 VIVACIT-E PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. 65323993 00889024520547

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R SEE H11 NARRATIVE.