BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP ANATOMIC VERSA-DIAL TAPER ADAPTOR 25MM

    MDR report key: 21764657 · Received April 3, 2025

    Report

    Report Number
    0001825034-2025-00986
    Event Type
    Injury
    Date Received
    April 3, 2025
    Date of Event
    March 6, 2025
    Report Date
    May 8, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    UDI-DI
    00880304834026
    PMA / PMN Number
    K202232
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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 WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: MEDICAL PRODUCTS: ITEM#: 115310, COMP RVRS SHLDR GLNSP STD 36MM; LOT#: J7799890. ITEM#: 110044360, 36MM STANDARD RETENTIVE BEARING; LOT#: 65854051. ITEM#: SAHTNEM6, -6MM EXTENDED NEUTRAL HUMERAL TRAY; LOT#: 66984413. ITEM#: SAHS1104, SIZE 4 STANDARD HUMERAL STEM; LOT#: 66511654. ITEM#: 115399, COMP RVS CNTRL 6.5X45MM ST/RST; LOT#: 241360. ITEM#: 115400, COMP RVS CNTRL 6.5X50MM ST/RST; LOT#: 65888016. ITEM#: 180553, COMP LK SCR 3.5HEX 4.75X30 ST; LOT#: 65940765. ITEM#: 180553, COMP LK SCR 3.5HEX 4.75X30 ST; LOT#: 66654590. ITEM#: 180553, COMP LK SCR 3.5HEX 4.75X30 ST; LOT#: 66918176. ITEM#: 180554, COMP LK SCR 3.5HEX 4.75X35 ST; LOT#: 66890526. ITEM#: 180555, COMP LK SCR 3.5HEX 4.75X40 ST; LOT#: 66198202. ITEM#: 110027734, COMPR VRS GLEN PPS MIN TPR ADR; LOT#: 67077496. G2: FOREIGN: JAPAN. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT WAS DISCARDED BY THE HOSPITAL AS BIOHAZARD. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SHOULDER ARTHROPLASTY APPROXIMATELY TWO (2) MONTHS AGO. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO INFECTION APPROXIMATELY ONE (1) MONTH AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731383 COMP ANATOMIC VERSA-DIAL TAPER ADAPTOR 25MM SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES PHX ZIMMER BIOMET, INC. 67077498 00880304834026

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H