BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HUMERAL HEAD

    MDR report key: 12861702 · Received November 23, 2021

    Report

    Report Number
    0001822565-2021-03366
    Event Type
    Injury
    Date Received
    November 23, 2021
    Report Date
    March 2, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL/CORRECTED INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2021-03367-2; 0001822565-2021-03368-2. UPON RECEIVING ADDITIONAL INFORMATION OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE FINAL REPORT SHOULD BE VOIDED. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: H2; H3; H6 REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS RECEIVED. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED PROBABLE OSTEOLYSIS ALONG THE MEDIAL ASPECT OF THE HUMERAL NECK, ADDITIONALLY THE HUMERAL COMPONENT IS HIGH RIDING SECONDARY TO SECONDARY TO UNDERLYING RC TEAR. MODERATE TO LARGE GLENOHUMERAL JOINT EFFUSION WITH SYNOVITIS. FINDINGS SUGGEST OSTEOLYSIS INVOLVING THE NECK OF THE HUMERUS MEDIALLY. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2021-03367, 0001822565-2021-03368. MEDICAL PRODUCTS: ITEM#: UNKNOWN, UNKNOWN HUMERAL STEM; LOT#: UNKNOWN; ITEM#: UNKNOWN, UNKNOWN GLENOID; LOT#: UNKNOWN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE PATIENT, APPROXIMATELY ELEVEN (11) YEARS POST INITIAL LEFT TOTAL SHOULDER ARTHROPLASTY, THAT THEY WERE HAVING PAIN, SEVERE ARTHRITIS, AND UNABLE TO USE ARM. THE PATIENT UNDERWENT AN MRI AND THAT REPORT IDENTIFIED TENDON TEARS, OSTEOARTHRITIS, SYNOVITIS EFFUSION AND BURSITIS. NO FURTHER INFORMATION WAS PROVIDED.

    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 RIGHT SHOULDER ARTHROPLASTY APPROXIMATELY ELEVEN (11) YEARS AGO. SUBSEQUENTLY, THE PATIENT IS EXPERIENCING PAIN AND SEVERE ARTHRITIS THAT IS CAUSING THE PATIENT TO BE UNABLE TO USE RIGHT ARM. MRI RESULTS RECEIVED NOTED OSTEOLYSIS AND ROTATOR CUFF TEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1760645 UNKNOWN HUMERAL HEAD SHOULDER PROSTHESIS/EXTREMITIES PHX ZIMMER BIOMET, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other SEE H10 NARRATIVE