BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN COMPREHENSIVE REVERSE GLENOSPHERE

    MDR report key: 17239730 · Received June 30, 2023

    Report

    Report Number
    0001825034-2023-01461
    Event Type
    Injury
    Date Received
    June 30, 2023
    Date of Event
    June 21, 2023
    Report Date
    August 18, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EXACT IMPLANTATION DATE IS UNKNOWN HOWEVER IS NOTED TO HAVE OCCURRED YEARS PRIOR AFTER CONCOMITANT DEVICE MANUFACTURING DATE, BETWEEN (B)(6) 2019. MEDICAL PRODUCT: COMP RVRS 25MM BSPLT HA+ADPTR: CATALOG#010000589, LOT#968640; ARCOM XL 44-36 STD HMRL BRNG: CATALOG#XL-115363, LOT#416770; UNKNOWN COMPREHENSIVE REVERSE HUMERAL TRAY: CATALOG#NI, LOT#NI; COMP PRIMARY STEM 15MM MINI: CATALOG#113635; LOT#161830; UNKNOWN FIXATION SCREW: CATALOG#NI, LOT#NI, QTY#(B)(4). PROPOSED COMPONENT CODE: MECHANICAL (G04) - HEAD. ADDITIONAL REPORTS HAVE BEEN FILED FOR THIS EVENT. PLEASE SEE ADDITIONAL REPORTS: 0001825034-2023-01934; 0001825034-2023-01935; 0001825034-2023-01936; 0001825034-2023-01937. VISUAL AND DIMENSIONAL EVALUATIONS OF THE PRODUCT COULD NOT BE PERFORMED AS NO PRODUCT WAS RETURNED NOR WERE PICTURES PROVIDED. DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. THIS COMPLAINT IS NOT CONFIRMED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    CMP: (B)(4). D10: MEDICAL PRODUCT: COMP RVRS 25MM BSPLT HA+ADPTR: CATALOG#010000589, LOT#968640; ARCOM XL 44-36 STD HMRL BRNG: CATALOG#XL-115363, LOT#416770; UNKNOWN COMPREHENSIVE REVERSE HUMERAL TRAY: CATALOG#NI, LOT#NI; COMP PRIMARY STEM 15MM MINI: CATALOG#113635; LOT#161830. REPORT SOURCE FOREIGN: UNITED KINGDOM. MULTIPLE MDR REPORTS HAVE BEEN FILED FOR THIS REPORT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2023-01460; 0001825034-2023-01462; 0001825034-2023-01463; 0001825034-2023-01464. DILIGENCE IS IN PROGRESS TO DETERMINE WHETHER THE PRODUCT WILL BE RETURNING TO ZIMMER BIOMET FOR EVALUATION. THE INVESTIGATION IS IN PROGRESS. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL SHOULDER REPLACEMENT SURGERY. SUBSEQUENTLY, APPROXIMATELY FOUR (4) YEARS POST-IMPLANTATION THE PATIENT UNDERWENT REVISION SURGERY TO IMPROVE FUNCTION AND RELIEVE PAIN. DUE DILIGENCE IS IN PROGRESS FOR THIS EVENT; TO DATE NO FURTHER INFORMATION HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1484878 UNKNOWN COMPREHENSIVE REVERSE GLENOSPHERE PROSTHESIS, SHOULDER PHX ZIMMER BIOMET, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Hospitalization| R SEE H10 NARRATIVE.| SEE H10 NARRATIVE.