ARTHREX, INC. ECLIPSE TRUNION 47MM, SLOTTED, TPS CAP; TOTAL SHOULDER ARTHROPLASTY SYSTEM
|
Back to Search Results |
|
Model Number ECLIPSE TRUNION 47MM, SLOTTED, TPS CAP |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
Event Date 07/22/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
|
|
Event Description
|
It was reported that a patient underwent a revision shoulder procedure on (b)(6) 2021 where an arthrex implant was removed.No further details, additional information has been requested.Additional information provided 8/19/2021: the date of the primary procedure was on (b)(6)2021 for a left total shoulder arthroplasty.This procedure took place at gateway surgery center, arthrex account # (b)(4).Revision for a left anatomic total shoulder arthroplasty to reverse shoulder arthroplasty took place at arthrex account # (b)(4)on (b)(6) 2021 where the following devices were explanted: ar-9301-02 (20.00960); ar-9301-47cpc (19.04096); ar-9347-20 (2797, 47/20); ar-9121-06 (17.01402).
|
|
Manufacturer Narrative
|
Complaint not confirmed, no abnormality was observed that may have contributed to the event.Only minor wear and abrasion were observed that is expected from an explanted device.
|
|
Search Alerts/Recalls
|
|
|