BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MD HYBRID GLENOID BASE 4MM

    MDR report key: 15300032 · Received August 26, 2022

    Report

    Report Number
    0001825034-2022-01923
    Event Type
    Injury
    Date Received
    August 26, 2022
    Date of Event
    July 19, 2022
    Report Date
    December 7, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBF
    UDI-DI
    00887868267772
    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. 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. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT WAS REQUESTED BUT PER HOSPITAL POLICY WAS NOT RETURNED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2022-01922-1 0001825034-2022-02758 D10: MEDICAL PRODUCTS: ITEM#: PT-113950, PT HYBRID GLEN POST REGENEREX; LOT#: 370430. 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 THE PRODUCT HAS BEEN EXPLANTED AND STILL ASSEMBLED TO MATING IMPLANT. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. 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 08-FEB-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 IS WAS REVISED DUE TO LOOSENING OF IMPLANTS AND A INFECTION. ALL COMPONENTS WERE REMOVED AND REPLACED WITH AN ANTIBIOTIC CEMENT SPACER.

    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
    2020061 MD HYBRID GLENOID BASE 4MM SHOULDER PROSTHESIS, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED/EXTREMITIES MBF ZIMMER BIOMET, INC. 113630 899530 00887868267772

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Hospitalization| R SEE H10 NARRATIVE.| SEE H10 NARRATIVE.