MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS APEX STEM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	AR-9501-12S
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870); Failure of Implant (1924)
Date of Event	02/03/2021
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that the surgeon implanted a univers revers apex and modular glenoid system (mgs) construct during a primary right reverse total shoulder arthroplasty case.The patient increased activity per the standard protocol.At 19 months post-op, the patient fell and had a periprosthetic fracture.At the time of revision for the periprosthetic fracture, the patient had a stable modular glenoid system implant construct.The revers apex humeral implants were removed.The wright medical revive revision humeral stem was implanted due to the periprosthetic fracture.At 26 months post-op from the initial index reverse total shoulder procedure, the patient presented with no function.X-rays showed a failed modular glenoid system implant construct.The inferior screw was broken and the implants had shifted.On (b)(6) 2021, a second revision was performed to remove the modular glenoid system implants.The glenoid implants were removed in one piece with no bone on growth.A wright medical reverse glenoid construct was implanted in place.No infection.

• Brand Name: UNIVERS REVERS APEX STEM
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11798915
• Report Number: 1220246-2021-03040
• Device Sequence Number: 17268968
• Product Code: PHX
• UDI-Device Identifier: 00888867250536
• UDI-Public: 00888867250536
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K170414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/10/2021

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: AR-9501-12S
• Device Catalogue Number: AR-9501-12S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 05/10/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other