BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PT HYBRID GLEN POST REGENEREX

    MDR report key: 15946090 · Received December 8, 2022

    Report

    Report Number
    0001825034-2022-02758
    Event Type
    Injury
    Date Received
    December 8, 2022
    Date of Event
    July 19, 2022
    Report Date
    December 7, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBF
    UDI-DI
    00880304459854
    PMA / PMN Number
    K193038
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    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: 0001825034-2022-01922-1. 0001825034-2022-01923-1. CONCOMITANT MEDICAL PRODUCTS: ITEM#: 113042, VERSA-DIAL 46X18X53 HUM HEAD; LOT#: 190190, ITEM#: 118001, VERSA-DIAL/COMP TI STD TAPER; LOT#: 814790, ITEM#: 113630, COMP PRIMARY STEM 10MM MINI; LOT#: 992200, ITEM#: 113954, MD HYBRID GLENOID BASE 4MM; LOT#: 899530. 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, THEREFORE IMPLANTED PRODUCTS ARE NOT IDENTIFIED AS THE SOURCE OR CONTRIBUTING TO THE REPORTED INFECTION. VISUAL EXAMINATION OF THE PROVIDED PICTURE IDENTIFIED THAT PRODUCT HAS BEEN EXPLANTED AND IS TILL ASSEMBLED TO MATING IMPLANT. PART AND LOT NUMBERS CANNOT BE CONFIRMED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. RADIOGRAPHS WERE PROVIDED; HOWEVER, THEY WERE NOT SUBMITTED FOR REVIEW AS THE IMAGES ARE IN THE IMMEDIATE POSTOP TIMEFRAME AS REFLECTED BY THE STAPLE LINE PRESENT. SENDING THE IMAGES WOULD NOT ENHANCE THE INVESTIGATION. IMAGES TAKEN (B)(6) 2017. 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 THAT A PATIENT UNDERWENT AN INITIAL RIGHT SHOULDER ARTHROPLASTY. SUBSEQUENTLY, APPROXIMATELY SEVEN (7) YEARS LATER, THE PATIENT WAS REVISED DUE TO LOOSENING OF IMPLANTS AND AN INFECTION. ALL COMPONENTS WERE REMOVED AND REPLACED WITH AN ANTIBIOTIC CEMENT SPACER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2915332 PT HYBRID GLEN POST REGENEREX PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED/EXTREMITIES MBF ZIMMER BIOMET, INC. PT-113950 370430 00880304459854

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Hospitalization| R