BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BASEPLATE S 15MM

    MDR report key: 19626291 · Received June 27, 2024

    Report

    Report Number
    0009613350-2024-00253
    Event Type
    Injury
    Date Received
    June 27, 2024
    Date of Event
    June 20, 2024
    Report Date
    October 15, 2024
    Manufacturer
    ZIMMER GMBH
    Product Code
    PHX
    UDI-DI
    00889024490314
    PMA / PMN Number
    K193099
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. G2: FOREIGN: JAPAN. D10: LINER S, ITEM #0104440012, LOT# 2993054; OSC BLD 19X1.27X90, ITEM #TN190-127-90, LOT# 1055949; ACCESS 3.2MM THD STEINMANN 9, ITEM #110003484, LOT# 285220; COMPR NANO HMRL PPS 38MM, ITEM #115738, LOT# 171050; DPSC SCREW 3.5/4.5X18MM, ITEM #0104440018, LOT# 3010122; DPSC SCREW 3.5/4.5X27MM, ITEM #0104440027, LOT# 2996243; VERSADIAL 42X21X43 HUM HD CAST, ITEM #113134, LOT# 066950; VERSA-DIAL/COMP TI STD TAPER, #118001, LOT# 399140; COMPR NANO 7IN STEINMANN PIN, ITEM #31-406990, LOT# 447980. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 0

    (B)(4). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT HAD A REVISION SURGERY APPROXIMATELY 4 YEARS AFTER IMPLANTATION DUE TO DISASSOCIATION OF THE GLENOID BASEPLATE FROM THE LINER. UPON REMOVAL IT WAS ALSO FOUND THAT THE BASEPLATE WAS FRACTURED. THE PATIENT COMPLAINED OF PAIN AND A REVISION SURGERY WAS PERFORMED WITH COMPREHENSIVE REVERSE SHOULDER SYSTEM. THE PATIENT MATCHED IMPLANT REQUEST REPORTED INITIALLY FOR THIS CASE WAS NO LONGER NEEDED. DUE DILIGENCE HAS BEEN COMPLETED FOR THIS COMPLAINT; TO DATE ALL AVAILABLE ADDITIONAL INFORMATION HAS BEEN RECEIVED.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WILL HAVE A REVISION FOR A PATIENT MATCHED IMPLANT DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430218 BASEPLATE S 15MM SHOULDER PROTHESIS PHX ZIMMER GMBH N/A 3019007 00889024490314

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Male Other| R| H SEE H11 NARRATIVE.