BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUAL MOBILITY VIVACIT E

    MDR report key: 22809634 · Received August 14, 2025

    Report

    Report Number
    0001822565-2025-02944
    Event Type
    Injury
    Date Received
    August 14, 2025
    Report Date
    December 2, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024572706
    PMA / PMN Number
    K190656
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CAT: 650-1055 LOT: 3031481 CER BIOLOXD OPTION HD 28MM. CAT: 650-1065 LOT: 3048758 CER OPTION TYPE 1 TPR SLEVE -3. CAT: 010000664 LOT: 7035252 G7 PPS LTD ACET SHELL 54F. CAT: 110024464 LOT: 370560 G7 DUAL MOBILITY LINER 44MM F. CAT: 51-107110 LOT: 6883354 TPRLC 133 MP TYPE1 PPS HO 11.0. THE 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

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: G3; H2; H3; H6; H10. THE FOLLOWING SECTIONS WERE CORRECTED: B2; D4 UDI. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. COMPLAINT IS NOT 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 POST-IMPLANTATION, THE PATIENT IS EXPERIENCING MULTIPLE ISSUES: A METALLIC TASTE IN THE MOUTH AND HAS CORRESPONDING NICKEL ALLERGY; A RASH ON THEIR LEG; FEELINGS OF THEIR FEMUR SHIFTING; TWO ROUNDS OF ANTIBIOTIC TREATMENT AND IV ANTIBIOTICS FOR INFECTION; INABILITY TO WALK MUCH; TOES GO NUMB WHEN LAYING ON SIDE; HEART ATTACK LIKE SYMPTOMS; BACK PAIN; POTASSIUM AND MAGNESIUM INFUSIONS FOR UNKNOWN REASON MAKING THEM FEEL WORSE; ALLEGED METAL IN URINE THAT SURGEON THINKS IS A KIDNEY STONE; OTHER GREEN PARTICLES IN URINE SUSPECTED AS SUTURE PIECES. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783008 DUAL MOBILITY VIVACIT E PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. 64934263 00889024572706

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other| R