BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVRS 25MM BSPLT HA+ADPTR R

    MDR report key: 10683045 · Received October 15, 2020

    Report

    Report Number
    0001825034-2020-03792
    Event Type
    Injury
    Date Received
    October 15, 2020
    Date of Event
    September 30, 2020
    Report Date
    November 3, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    PMA / PMN Number
    K120121
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. 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 IS AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). PROCODE: PHX. CONCOMITANT MEDICAL DEVICES: COMP RVS CNTRL 6.5X20MM ST/RST CAT# 115394 LOT# 011430; COMP LK SCR 3.5HEX 4.75X20 ST CAT# 180551 LOT# 638000; COMP RVS 2.7MM DIA DRL LL CAT# 405889 LOT# 198780; COMP LK SCR 3.5HEX 4.75X20 ST CAT# 180551 LOT# 752820; COMP LK SCR 3.5HEX 4.75X20 ST CAT# 180551 LOT# 499360; COMP LK SCR 3.5HEX 4.75X35 ST CAT# 180554 LOT# 676000; COMP PRIMARY STEM 5MM MINI CAT# 113625 LOT# 528120; ARCOM XL 44-36 STD HMRL BRNG CAT# XL-115363 LOT# 791980; COMP RVS TRAY CO 44MM CAT# 115370 LOT# 941850; COMP RVRS SHLDR GLNSP STD 36MM CAT# 115310 LOT# 087620. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT APPROXIMATELY 16 MONTHS POST IMPLANTATION DUE TO LOOSENING. 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
    1150850 COMP RVRS 25MM BSPLT HA+ADPTR R PROSTHESIS, SHOULDER PHX ZIMMER BIOMET, INC. NI 197250

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R