BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVSR SHLDR GLNSP +3 36MM

    MDR report key: 16601426 · Received March 23, 2023

    Report

    Report Number
    0001825034-2023-00625
    Event Type
    Injury
    Date Received
    March 23, 2023
    Date of Event
    February 23, 2023
    Report Date
    July 14, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    UDI-DI
    00880304475779
    PMA / PMN Number
    K193373
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. H6: PROPOSED ANNEX G CODE: MECHANICAL (G04) - HEAD. VISUAL EXAMINATION OF THE RETURNED PRODUCT/PROVIDED PICTURES IDENTIFIED THE GLENOSPHERE SHOWS SIGNS  OF WEAR AND TEAR WITH MAJOR SCRATCHES AND SCUFFS ON THE POLISHED SURFACE. THE PART AND LOT NUMBERS OF THE RETURNED PRODUCT CONFIRM  THOSE REPORTED IN THE COMPLAINT. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. ASSOCIATED PRODUCTS AND REPORTS: 0001822565-2023-00796: ITEM#00434906506; LOT#65566647. 0001822565-2023-00797: ITEM# UNKNOWN STEM; LOT# UNKNOWN. OTHER ASSOCIATED PRODUCTS: ITEM#00-4349-066-06; LOT#63676333. ITEM#110030777; LOT#65560519. ITEM#010000589; LOT#881160. ITEM#115313; LOT#J7407973. ITEM#118000; LOT#J7329702.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED A PATIENT UNDERWENT A SHOULDER REVISION DUE TO DISLOCATION. DURING THE PROCEDURE, IT WAS NOTED THE POLYETHYLENE HAD DISASSOCIATED FROM THE STEM. THE GLENOSPHERE AND POLYETHYLENE WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1444559 COMP RVSR SHLDR GLNSP +3 36MM SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ZIMMER BIOMET, INC. NI J7407973 00880304475779

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R SEE NARRATIVE IN H10