BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUAL MOBILITY VIVACIT-E BEARING SIZE D

    MDR report key: 19615466 · Received June 26, 2024

    Report

    Report Number
    0001822565-2024-02146
    Event Type
    Injury
    Date Received
    June 26, 2024
    Date of Event
    June 14, 2024
    Report Date
    December 10, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024572683
    PMA / PMN Number
    K190656
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: B4; B5; G3; H2; H3; H4; H6. VISUAL REVIEW OF THE RETURNED LINER IS UNABLE TO CONFIRM ITEM OR LOT AS THERE IS NO ETCH ON SIZE 40MM PER DELTA NOTE 1 ON THE PRINT. LINER SHOWS INDENTATIONS TO THE OTHER SPHERICAL SURFACE. NICKS IN THE INNER SPHERICAL SURFACE AND ON THE RIM. NO OTHER DAMAGE WAS NOTED. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. A REVIEW OF THE AVAILABLE RECORDS IDENTIFIED FINDINGS OF THE REPORTED ISSUES. IMPRESSIONS: RECENT POSTSURGICAL CHANGES FROM LEFT TOTAL HIP ARTHROPLASTY WITH EVIDENCE OF SUPERIOR AND LIKELY POSTERIOR DISLOCATION OF THE FEMORAL COMPONENT. THE EVENT OF DISASSOCIATION BETWEEN THE HEAD/BEARING IS CONFIRMED VIA MEDICAL RECORDS. DHR WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CAT#00877502802; LOT#3201984; BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 28/0, TAPER 12/14. G2: FOREIGN ¿ BELGIUM. THE CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THE PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY ONE DAY POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO A FALL THAT WAS CAUSED BY PAIN AND THEN THE HIP DISLOCATED. DURING SURGERY, THE SURGEON FOUND AN INTRA-PROSTHETIC DISLOCATION OF THE HEAD OUT OF THE BEARING. THE HEAD AND BEARING WERE REVISED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY ONE DAY POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO A FALL AND HIP DISLOCATION. DURING SURGERY, THE SURGEON FOUND AN INTRA-PROSTHETIC DISLOCATION OF THE HEAD OUT OF THE BEARING. THE HEAD AND BEARING WERE REVISED.ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY ONE DAY POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO A FALL AND HIP DISLOCATION. DURING SURGERY, THE SURGEON FOUND AN INTRA-PROSTHETIC DISLOCATION OF THE HEAD OUT OF THE BEARING. THE STEM, HEAD, AND BEARING WERE REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577645 DUAL MOBILITY VIVACIT-E BEARING SIZE D PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 65560546 00889024572683

    Patients

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