BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVENIR CMPL HA VAR NC SIZE 5

    MDR report key: 18758153 · Received February 22, 2024

    Report

    Report Number
    0001822565-2024-00625
    Event Type
    Injury
    Date Received
    February 22, 2024
    Date of Event
    November 9, 2023
    Report Date
    June 20, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    UDI-DI
    00889024508910
    PMA / PMN Number
    K182048
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2024-00623; 0001822565-2024-00624; 0001825034-2024-00483. D10: CAT #: 30123605 / G7 VIT E HIGH WALL LNR 36MM E / LOT #: 65312753. CAT #: 802203603 / ZB 12/14 COCR HD 36MM X +3.5 / LOT #: 3089098. CAT #: 010000663 / G7 PPS LTD ACET SHELL 52E / LOT #: 7132998. G2: DENMARK. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 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/CORRECTED. UPDATED: B4; B5; D4; G3; H2; H3; H4; H6. PROPOSED COMPONENT CODE: MECHANICAL (G04)- STEM. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: THE PATIENT DEVELOPED PAIN, WITH DIFFICULTY AMBULATING POST-OP. ONE YEAR LATER, THE PAIN PERSISTED SO THE PATIENT WAS REVISED DUE TO STEM SUBSIDENCE AND LOOSENING NOTED. ALL DEVICES WERE EXPLANTED WITH UNKNOWN PRODUCTS PLACED. THE COMPLAINT WAS CONFIRMED BASED ON THE PROVIDED 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.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING A CLINICAL STUDY THAT AT THE ONE-YEAR POST-OP APPOINTMENT, THE PATIENT WAS EXPERIENCING MODERATE PAIN, DIFFICULTY WITH AMBULATION AND DAILY ACTIVITIES. SUBSIDENCE OF THE STEM WAS NOTED AS WELL. THEN, THE PATIENT UNDERWENT A RIGHT HIP REVISION APPROXIMATELY TWO YEARS POST IMPLANTATION DUE TO PAIN, DIFFICULTY WITH AMBULATION AND DAILY ACTIVITIES. THE PATIENT WAS REMOVED FROM THE STUDY AND A REVISION OF ALL THE COMPONENTS WAS COMPLETED WITHOUT ANY KNOWN COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63881 AVENIR CMPL HA VAR NC SIZE 5 PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. NI 3064721 00889024508910

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R SEE H10 NARRATIVE