BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPR 8MM HUM FRACT STEM PPS

    MDR report key: 12312769 · Received August 12, 2021

    Report

    Report Number
    0001825034-2021-02386
    Event Type
    Injury
    Date Received
    August 12, 2021
    Report Date
    October 22, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    PMA / PMN Number
    K140652
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D4, G3, G6, H2, H6, H10 NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. IT IS ALLEGED THE FRACTURE AND DISLOCATION WERE IDENTIFIED AFTER A FALL; HOWEVER, 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.

    Additional Manufacturer Narrative · 0

    (B)(4). 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 IS AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). PROCODE: PHX. CONCOMITANT MEDICAL DEVICES: COMP RVRS SHLDR GLNSP +6 36MM CAT# 115316 LOT# 821910; CR PROLONG 36MM BRNG +3 RET CAT# 110031420 LOT# 64489317. 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 - 2021 - 02385.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT IS BEING CONSIDERED FOR A REVISION AT AN UNKNOWN DATE DUE TO DISLOCATION AND HUMERAL FRACTURE. SURGEON HAS REQUESTED A CUSTOM VRS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1210651 COMPR 8MM HUM FRACT STEM PPS PROSTHESIS, SHOULDER PHX ZIMMER BIOMET, INC. NI 785030

    Patients

    Seq Age Sex Outcome Treatment
    1 Other SEE H10