BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA-DIAL 38X19X39 HUM HEAD

    MDR report key: 10958553 · Received December 7, 2020

    Report

    Report Number
    0001825034-2020-04242
    Event Type
    Injury
    Date Received
    December 7, 2020
    Report Date
    March 3, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    K040610
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: SURGERY ENCOUNTERED HEMORRHAGE UNDERNEATH THE DELTOID AND OLD CLOTS WHICH WERE REMOVED. 1 DAY POSTOP- DISCHARGE ¿ HEMOVAC DRAIN REMOVED, X-RAY POST-OP STABLE, RTO 10 DAYS FOR SUTURE REMOVAL. 8 MONTHS POSTOP- POST RIGHT SHOULDER TOTAL SHOULDER FROM COMMINUTED FRACTURE, AND PHYSICAL THERAPY, WEAKNESS AND INABILITY TO ABDUCT SHOULDER. ARTHROGRAM PERFORMED POSITIVE FOR POSSIBLE ROTATOR CUFF TEAR. OPEN EXPLORATION OF ROTATOR CUFF UNDER BLOCK AND GENERAL ANESTHESIA. DEFINITIVE HOLE IN SUPRASPINATUS 1/4IN IN DIAMETER. SUPRASPINATUS WAS INTACT, BUT WAS POORLY ATTACHED TO LATERAL CORTICES OF HUMERUS. ADHESIONS/SCAR TISSUE RELEASED, AND REINFORCEMENT OF SUPRASPINATUS PERFORMED. NO COMPLICATIONS, PLACED IN IMMOBILIZER. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. 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

    NO FURTHER EVENT INFORMATION AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES: COMP PRIMARY STEM 11MM MINI CAT# 113631 LOT# 830090; SM HYBRID GLENOID BASE 4MM CAT# 113952 LOT# 999610; VERSA-DIAL/COMP TI STD TAPER CAT# 118001 LOT# 558060; PT HYBRID GLEN POST REGENEREX CAT# PT-113950 LOT# 478220; BIOMET BC R 1X40 US CAT# 110035368 LOT# 825BAF1806. THE EVENT WAS INITIALLY REPORTED ON 0001822565-2020-03515. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2020 - 04239, 0001825034 - 2020 - 04240, 0001825034 - 2020 - 04241, 0001825034 - 2020 - 04243.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT ALLEGES EXPERIENCING PAIN AND THE DEVICE MOVES OUT OF PLACE APPROXIMATELY ONE YEAR POST IMPLANTATION. PATIENT ALLEGES THE DEVICES MOVE AROUND IN WAYS THEY ARE NOT SUPPOSED TO. NO REVISION HAS BEEN REPORTED TO DATE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1424303 VERSA-DIAL 38X19X39 HUM HEAD PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. NI 314040

    Patients

    Seq Age Sex Outcome Treatment
    1 Other SEE H10