Model Number 04.01.0208 |
Device Problem
Migration or Expulsion of Device (1395)
|
Patient Problem
Insufficient Information (4580)
|
Event Date 04/05/2022 |
Event Type
Injury
|
Event Description
|
The patient came in for a post-op appointment and it was revealed that the glenosphere eccentricity has shifted superiorly.The surgeon plans to revise the patient on (b)(6) 2022.Primary surgery was performed in (b)(6) 2021.
|
|
Manufacturer Narrative
|
Batch review performed on 29-apr-2022.Lot 2005601a: (b)(4) items manufactured and released on 26-jan-2021.Expiration date: 2026-01-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Clinical evaluation performed by medical affairs director one year after rsa, at a follow up visit the glenosphere is found rotated versus the initial position.From the radiograph supplied, it appears that it may also have detached in part from the taper spigot of the baseplate.This may be due to incomplete seating of the baseplate fixation screws, to a quasi-traumatic event, or to another factor that we cannot trace with the information at hand.Re-positioning of the glenosphere is highly recommendable if the patient conditions allow.Other device involved: batch review performed on 29-apr-2022.Reverse shoulder system 04.01.0191 threaded glenoid baseplate ø24.5x30 (k171058) lot 1904749: (b)(4) items manufactured and released on 04-dec-2019.Expiration date: 2024-11-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
|
|
Event Description
|
The patient came in for a post-op appointment and it was revealed that the glenosphere eccentricity has shifted superiorly.After different e-mails on 08.07.2022 we concluded that due to a misunderstanding the all details, event description included are wrong.The patient had nothing wrong, it was not revised and had not any adverse event.
|
|
Manufacturer Narrative
|
Correction: after different e-mails on 08.07.2022 we concluded that due to a misunderstanding the all details, event description included are wrong.The patient had nothing wrong, it was not revised and had not any adverse event.All components are managed as associated items.
|
|
Search Alerts/Recalls
|