BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTION TAPER SLEEVE, -3MM NECK, TYPE 1 TAPER

    MDR report key: 15914603 · Received December 5, 2022

    Report

    Report Number
    3002806535-2022-00489
    Event Type
    Injury
    Date Received
    December 5, 2022
    Date of Event
    September 14, 2022
    Report Date
    December 21, 2022
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    UDI-DI
    00887868271472
    PMA / PMN Number
    K200959
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MEDICAL PRODUCTS; BIOLOX DELTA OPTION HEAD, 40MM, ITEM# 650-1058, LOT# 3041313. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535 -2022 -00488. 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 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. D10: 40MM I.D. SIZE G NEUTRAL LINER, ITEM# 30104007, LOT# 65338076. DURING THE INVESTIGATION PROCESS A REVIEW OF THE STERILE CERTIFICATIONS WERE REVIEWED AND FOUND TO BE CONFORMING WITH NO APPLICABLE DEVIATIONS. DEVICES WERE VERIFIED TO HAVE GONE THROUGH ACCEPTABLE STERILIZATION PROCESS FOLLOWING ISO/AAMI/ASTM & EU PUBLISHED GUIDELINES. THERE ARE MULTIPLE FACTORS THAT MAY CONTRIBUTE TO AN INFECTION THAT ARE OUTSIDE THE CONTROL OF ZIMMER BIOMET, SUCH AS EXTERNAL FACTORS, I.E. HOSPITAL/SURGICAL ENVIRONMENT, PROVIDER RELATED RISK FACTORS, AND/OR PATIENT COMORBIDITIES/RISK FACTORS. AS THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUES IDENTIFIED AFFECTING IMPLANT SAFETY OR EFFECTIVENESS, IMPLANTED PRODUCTS ARE NOT IDENTIFIED AS THE SOURCE OR CONTRIBUTING TO THE REPORTED INFECTION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS REVISED 23-DAYS POST-IMPLANTATION, DUE TO A SUPERFICIAL INFECTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815731 OPTION TAPER SLEEVE, -3MM NECK, TYPE 1 TAPER PROSTHESIS, HIP LZO BIOMET UK LTD. N/A 3087469 00887868271472

    Patients

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