BEUDAMED
    FDA Adverse Event Other Summary report: N

    G7 OSSEOTI ACETABULAR SHELL

    MDR report key: 17756560 · Received September 14, 2023

    Report

    Report Number
    MW5145689
    Event Type
    Other
    Date Received
    September 14, 2023
    Report Date
    September 13, 2023
    Manufacturer
    ZIMMER BIOMET/ZIMMER, INC.
    Product Code
    LPH
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PINNACLE LITIGATION RECORD RECEIVED. PATIENT ALLEGES ELEVATED METAL ION RESULTING IN INJURY, SUFFERED ADDITIONAL SCAR TISSUE FORMATION, PAIN, TISSUE DESTRUCTION, METAL WEAR, METAL POISONING, LOSS OF ENJOYMENT OF LIFE, LIMITATION OF DAILY ACTIVITIES, EMOTIONAL TRAUMA AND DISTRESS, AND PHYSICAL DISABILITIES. MRI(MAGNETIC RESONANCE IMAGING) FINDINGS ON (B)(6) 2022 DESCRIBE LEFT HIP ARTHROSIS WITH MARGINAL RIDGING CHONDRAL THINNING AND DEGENERATION SIGNAL CHANGES IN THE ACETABULUM, THERE IS MILD LEFT TROCHANTERIC BURSITIS. LATERAL IMAGES DEMONSTRATE DIFFUSE ATTENUATION, ABNORMAL SIGNAL AND TEARING OF THE LEFT ANTERIOR SUPERIOR TO THE POSTERIOR SUPERIOR LABRUM. THE FOLLOWING COMPETITOR IMPLANTS WERE PLACED AT THE TIME. REFERENCE REPORT: MW5145688, MW5145690. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295134 G7 OSSEOTI ACETABULAR SHELL PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH ZIMMER BIOMET/ZIMMER, INC. 6424103

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown BIOLOX DELTA, CERAMIC FEMORAL HEAD| G7 ACETABULAR LINER