MAUDE Adverse Event Report: ARTHREX, INC. UNI GLENOID-PERIPHERAL LOCK SCRW; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	UNI GLENOID-PERIPHERAL LOCK SCRW
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint confirmed, the device was returned with two broken lateral screws ar-9145-24.The most likely cause of the glenoid sided failure is fall/ trauma, as stated in the event description.
Event or Problem Description
It was reported that on (b)(6) 2019 a revers shoulder arthroplasty was performed.Everything went well and it was finished successfully.The surgeon was satisfied after the case.This was also showed on the x-rays.Approximately 6 months post-op the patient reported subsequently failing while putting on trousers.He felt an issue.This was when the glenoid side gave way.It was an elective revers and not a fracture revers.X-rays were done on (b)(6) 2020.A revision surgery is planned to be on (b)(6) 2020.Update swit: 02-apr-2020: further information was received: the revision surgery went ahead on (b)(6) 2020 afternoon.It was revised with the new modular glenoid system, successfully using an iliac crest graft.Everything went very well.The failed devices were retrieved, however both peripheral screws were broken and the tips remain in the patient.Baseplate, central screw & remaining portion of peripheral screws x 2 will be returned assembled.Also from the humeral side the cup and liner, which needed to be removed for access, will be returned.There was no issue with the humeral side, however they will be returned regardless.Follow-up update on 29-apr-2020: further information was provided that the patient was elderly and the bone quality was not in top condition but also not too bad.The damage to the implants occurred (as the patient claims) when putting on trousers, this necessitated the revision, they did not break on removal, they were already broken from whatever trauma they suffered.It was further reported that it is very unlikely that just putting on trousers caused both screws to break.

• Brand Name: UNI GLENOID-PERIPHERAL LOCK SCRW
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10074745
• Report Number: 1220246-2020-01847
• Device Sequence Number: 2900281
• Product Code: PHX
• UDI-Device Identifier: 00888867057715
• UDI-Public: 00888867057715
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K142863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: UNI GLENOID-PERIPHERAL LOCK SCRW
• Device Catalogue Number: AR-9145-24
• Device Lot Number: 19.00006
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2020
• Initial Report FDA Received Date: 05/20/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other