MAUDE Adverse Event Report: ARTHREX, INC. 36+3 / 39 COMBINATION HUMERAL INSERT; SHOULDR PROSTH, REVERSE CONFIG

Model Number	36+3 / 39 COMBINATION HUMERAL INSERT
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/08/2024
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
On 1/9/2024, it was reported on case number: (b)(4) by a sales representative via sems-06451329 that a revision reverse tsa procedure occurred on (b)(6) 2024 for unknown reasons.During the procedure, it was reported that an ar-9545-t15-01 driver shaft was stripped when trying to remove screws from the mgs baseplate.The case was completed successfully, with no reported patient harm and no further information provided.No pieces broke inside the patient.Additional information has been requested on what caused the necessary revision surgery on (b)(6) 2024 on sems-06451329 for case number: (b)(4).Additional information was received on 1/31/2024: on 1/9/2024, it was reported by a sales representative via sems-06451329 that a patient had undergone a revision reverse tsa procedure on (b)(6) 2024 due to an infection.All components had to be removed, and the suture cup had to be separated from the stem for explantation.The original procedure was performed on (b)(6) 2023 at the same facility.No new products were implanted after explantation.The case was completed using another ar-9545-t15-01 driver shaft to remove the suture cup.The surgeon stated the patient's current health status had been reported as good.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to a patient-specific event.

• Brand Name: 36+3 / 39 COMBINATION HUMERAL INSERT
• Common Device Name: SHOULDR PROSTH, REVERSE CONFIG
• 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: emily shafer ; 8009337001
• MDR Report Key: 18624014
• Report Number: 1220246-2024-00675
• Device Sequence Number: 20684616
• Product Code: PHX
• UDI-Device Identifier: 00888867308862
• UDI-Public: 00888867308862
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K191960
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2025

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: 12/31/2024
• Device Model Number: 36+3 / 39 COMBINATION HUMERAL INSERT
• Device Catalogue Number: AR-9503-3639-3
• Device Lot Number: 19.03604
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2024
• Supplement Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 02/01/2024
• Supplement Report FDA Received Date: 04/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown