BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI HUMERAL TRAY STANDARD THICKNESS +0 MM TAPER OFFSET 40 MM DIAMETER

    MDR report key: 10968918 · Received December 8, 2020

    Report

    Report Number
    0001822565-2020-03984
    Event Type
    Injury
    Date Received
    December 8, 2020
    Date of Event
    November 17, 2020
    Report Date
    March 24, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    PMA / PMN Number
    K181611
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED THAT THE MINI HUMERAL TRAY STANDARD THICKNESS +0 MM TAPER OFFSET 40 MM DIAMETER DID NOT EXHIBIT ANY DAMAGE. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. 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: BEARING +3 MM THICKNESS 36 MM DIAMETER CAT# 110031419 LOT# 64343811; COMP RVRS SHLDR GLNSP STD 36MM CAT# 115310 LOT# 886340; 25MM VERSA-DIAL TAPER ADAPTOR CAT#118000-00 LOT#932950. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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: 0001822565 - 2020 - 03985.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A SHOULDER PROCEDURE. APPROXIMATELY 6 MONTHS LATER, THE PATIENT WAS REVISED DUE TO PAIN, CLICKING AND DISASSOCIATION. DURING THE REVISION, THE SURGEON NOTICED THE POLYETHYLENE HAD DISASSOCIATED FROM THE HUMERAL TRAY. THE GLENOSPHERE HAD ALSO COME IN CONTACT WITH THE HUMERAL TRAY AND HAD BEEN DAMAGED. THE DOCTOR REPLACED THE GLENOSPHERE, TAPER ADAPTOR, HUMERAL POLY, AND HUMERAL TRAY. 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
    1431030 MINI HUMERAL TRAY STANDARD THICKNESS +0 MM TAPER OFFSET 40 MM DIAMETER PROSTHESIS, SHOULDER PHX ZIMMER BIOMET, INC. NI 64666139

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R