BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP REV MINI HUM TRAY VIVAC-E 36MM STANDARD RETENTIVE BEARING

    MDR report key: 21764706 · Received April 3, 2025

    Report

    Report Number
    0001822565-2025-00883
    Event Type
    Injury
    Date Received
    April 3, 2025
    Date of Event
    March 6, 2025
    Report Date
    July 8, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBF
    UDI-DI
    00889024626461
    PMA / PMN Number
    K213856
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: MEDICAL PRODUCTS: ITEM#: SAHTNEM6, -6MM EXTENDED NEUTRAL HUMERAL TRAY; LOT#: 66984413, ITEM#: 110027734, COMPR VRS GLEN PPS MIN TPR ADR; LOT#: 67077496, ITEM#: 115310, COMP RVRS SHLDR GLNSP STD 36MM; LOT#: J7799890, ITEM#: 110031378, VERSA-DIAL TAPER ADAPTOR 25MM; LOT#: 67077498, 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. 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, G3, H2, H4, H6. THE FOLLOWING SECTION WAS CORRECTED: D5. H6 COMPONENT CODE: PRODUCT WAS NOT EVALUATION AS IT WAS DETERMINED THE EVENT IS NOT RELATED TO THE DEVICE. 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. ROOT CAUSE OF THE REPORTED EVENT IS NOT DEVICE RELATED. 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 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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION TO REPORT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1957437 COMP REV MINI HUM TRAY VIVAC-E 36MM STANDARD RETENTIVE BEARING PROSTHESIS, SHOULDER, SEMIT-CONSTRAINED, METAL/POLYMER, UNCEMENTED/EXTREMITIES MBF ZIMMER BIOMET, INC. 65854051 00889024626461

    Patients

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