BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUAL MOBILITY VIVACIT-E HIGHLY CROSSLINKED BEARING

    MDR report key: 19566991 · Received June 19, 2024

    Report

    Report Number
    0001822565-2024-02052
    Event Type
    Injury
    Date Received
    June 19, 2024
    Date of Event
    February 8, 2024
    Report Date
    August 15, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024572706
    PMA / PMN Number
    K190656
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CAT# 650-1055 LOT# 3123214 CER BIOLOXD OPTION HD 28MM. CAT# 15-103203 LOT# 500820 TAPERLOC MICROP LAT FMRL 9.0MM. CAT# US157850 LOT# 702030 M2A-MAGNUM PF CUP 50ODX44ID. CAT# 139252 LOT# 326930 M2A-MAGNUM 42-50MM TPR INSRT-6 0/-6MMT1. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS ITS LOCATION IS UNKNOWN. 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. 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 RELATED TO THE REPORTED EVENT. MEDICAL RECORDS WERE PROVIDED AND REVIEW IDENTIFIED THE FOLLOWING: DESPITE LENGTHENING SIGNIFICANTLY THROUGH THE NEW CERAMIC HEAD THE PATIENT DISLOCATED AND HAD DISSOCIATION OF THE DUAL MOBILITY UPON REDUCTION AND INSTABILITY, A DECISION WAS MADE TO IMPLANT A CONSTRAINED LINER WITH MULTIPLE SCREWS. THE FEMORAL COMPONENT WAS TESTED AND FOUND TO BE WELL-FIXED AND THEREFORE RETAINED, THE TRUNNION WAS PRISTINE. THE EXISTING ACETABULAR COMPONENT WAS REMOVED. AFTER FINAL LINER WAS PLACED, THE LOCKING MECHANISM WAS TESTED AND INTACT. TRIAL NECK AND HEAD WERE PUT IN PLACE AND TAKEN THROUGH ROM, STABILITY WAS EXCELLENT. NO EVIDENCE OF METAL WEAR, POLY HEAD OF DUAL MOBILITY IN GLUTEAL SLING, GREAT PRESS-FIT ON NEW ACETABULUM. NO COMPLICATIONS. MEDICAL TIMELINE: INITIAL TOTAL HIP ARTHROPLASTY AND REVISED TWELVE YEARS LATER DUE TO METAL RELATED PATHOLOGY AND ELEVATED METAL ION LEVELS. REVISION ONE MONTH LATER DUE TO DISLOCATION AND INSTABILITY. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE COMPLAINT IS CONFIRMED BASED ON THE MEDICAL RECORDS. 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 ONE MONTH POST-IMPLANTATION, THE PATIENT UNDERWENT A LEFT HIP REVISION DUE TO A DISLOCATION FOR UNKNOWN REASONS AND DISASSOCIATION OF THE DUAL MOBILITY WITH INSTABILITY UPON REDUCTION. THE DECISION WAS MADE TO REVISE THE PATIENT TO A CONSTRAINED PRODUCT. THE STEM WAS RETAINED. THE HEAD AND ACETABULAR COMPONENTS WERE REVISED. 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
    625508 DUAL MOBILITY VIVACIT-E HIGHLY CROSSLINKED BEARING PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 65817810 00889024572706

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H SEE H11 NARRATIVE