MAUDE Adverse Event Report: ARTHREX, INC. 36 +3 / 33 CONSTRND COMBO HUMERAL INSERT; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	36 +3 / 33 CONSTRND COMBO HUMERAL INSERT
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022, it was reported by a sales representative via phone that a patient had a left shoulder rtsa on (b)(6) 2020.On (b)(6) 2022, patient underwent a revision surgery due to chronic instability of the glenoid, which appeared to be worn out.However, sales representative could not confirm if any of the arthrex implanted devices had broken.During the revision surgery on (b)(6) 2022, an ar-9560-24 univers revers baseplate, ar-9561-25s univers revers central screw, an ar-9563-16 univers revers peripheral screw, an ar-9563-24 univers revers peripheral locking screw, an ar-9564-2433-lat univers revers glenosphere, an ar-9502f-36cpc univers revers suture cup, and an ar-9503-3633-3c univers revers constrained combo humeral insert were removed.Surgeon did not remove the univers revers stem that was implanted during original procedure on (b)(6) 2022.To complete the revision surgery, an ar-9502-36arca univers revers ca humeral head adapter and an ar-9550-19rca univers revers ca humeral head were implanted successfully.
Additional 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.

• Brand Name: 36 +3 / 33 CONSTRND COMBO HUMERAL INSERT
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 14468977
• Report Number: 1220246-2022-04943
• Device Sequence Number: 14753062
• Product Code: PHX
• UDI-Device Identifier: 00888867296619
• UDI-Public: 00888867296619
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K173900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/23/2022

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 Model Number: 36 +3 / 33 CONSTRND COMBO HUMERAL INSERT
• Device Catalogue Number: AR-9503-3633-3C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2022
• Initial Report FDA Received Date: 05/23/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown