BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-MOD HUM HEAD 48DIAX24MM

    MDR report key: 12085151 · Received June 29, 2021

    Report

    Report Number
    0001825034-2021-01889
    Event Type
    Injury
    Date Received
    June 29, 2021
    Report Date
    September 15, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWT
    PMA / PMN Number
    K030710
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: B4, B5, G3, H2, H3, H6 REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. MEDICAL RECORDS IDENTIFIED THE FOLLOWING: NO INTRA-OP COMPLICATIONS IDENTIFIED DURING THE INITIAL SURGERY. PATIENT STATED SHE WAS HAVING PAIN, LIMITED DAILY ACTIVITIES, BALANCE ISSUES, RANGE OF MOTION ISSUES, INABILITY HOLD ON TO THINGS, SLEEP LOSS, LOSS OF FEELING IN HER HAND, NECK AND BACK ISSUES. PATIENT STATED SHE WENT TO THE ER DUE TO INFLAMMATION AND SPASMS AFTER RECEIVING STEROID INJECTIONS. DURING THAT VISIT, SHE WAS TOLD THE METAL WAS COMING THROUGH HER SKIN. 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 UNDERWENT A LEFT SHOULDER REPLACEMENT. ALMOST TEN YEARS LATER, THE PATIENT HAS REPORTED CONSTANT PAIN, LIMITED DAILY ACTIVITIES, LOSS OF FEELING IN HER HAND, AND MOBILITY LOSS. SHE HAS RECEIVED STEROID INJECTIONS FOR INFLAMMATION AND SPASMS. NO REVISION HAS BEEN SCHEDULED TO DATE. ADDITIONALLY IT WAS REPORTED THAT THE MUSCLE IS DETACHING FROM THE ARM AND DEVICE IS COMING UP THROUGH THE SKIN.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES: REF 113849 LOT 415130 BIOMODULAR KEELED GLENOID; REF 113647 LOT 864650 COMPREHENSIVE STEM. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2021 - 01890; 0001825034 - 2021 - 01891.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT SHOULDER REPLACEMENT. ALMOST TEN YEARS LATER, THE PATIENT HAS REPORTED CONSTANT PAIN, LIMITED DAILY ACTIVITIES, LOSS OF FEELING IN HER HAND, AND MOBILITY LOSS. SHE HAS RECEIVED STEROID INJECTIONS FOR INFLAMMATION AND SPASMS. NO REVISION HAS BEEN SCHEDULED TO DATE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    978783 BIO-MOD HUM HEAD 48DIAX24MM PROSTHESIS, SHOULDER KWT ZIMMER BIOMET, INC. N/A 095790

    Patients

    Seq Age Sex Outcome Treatment
    1 Other SEE H10.