MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS HUMERAL STEM, SIZE 8; SHOULDR PROSTH HEMI- HUM UNCEM

Model Number	UNIVERS REVERS HUMERAL STEM, SIZE 8
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/19/2023
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 may 1st, 2024, a clindex notification was received indicating that a severe complication occurred, resulting in revision surgery to a patient listed in the shoulder arthroplasty registry.The patient underwent revision surgery on (b)(6) 2023 with cta head and glenoid grafting.Additional information received on 5/16/2024.The original tsa procedure was performed on (b)(6) 2009.The implants used in the original procedure were products from another manufacturing company.On (b)(6) 2023, the patient was seen by the surgeon due to several years of pain, and it was confirmed via ct arthrogram that the implants had loosened, and the patient had several rotator cuff tears.On (b)(6) 2023, the patient was revised from a tsa to a hemiarthroplasty in which the surgeon implanted a cta head and glenoid bone graft.Soon after the surgery, the patient still experienced pain and the surgeon suggested the patient might be a candidate for a state procedure to put in a baseplate.On (b)(6) 2024, the patient underwent a second revision surgery to convert the hemiarthroplasty to a revers tsa with a replant of the glenoid baseplate.Additional information received on 5/29/2024: during the revision surgery on (b)(6) 2024, an ar-9502f-36cpc arthrex univers revers suture cup, (b)(6) , lot number 23.01972, an ar-9555-15 arthrex univers revers spacer 36 + 15 mm lot number 22.02863, and an ar-9503s-06c arthrex univers revers humeral insert small / 36 / +6 / constrained lot number 23.02025 were implanted.During revision surgery on (b)(6) 23, an ar-9501-fx6wt univers revers fracture adapter, size 6-9, wide + ta ll lot number 98310, an ar-9501-09pt arthrex univers revers humeral stem, size 9 lot number 22.04154, an ar-9501ftk univers revers fracture adapter, trunnion lot number 21.00857, an ar-9501-08p arthrex univers revers humeral stem, size 8 lot number 22.03564 and an ar-9556-22rca univers revers ca humeral head 56/22 lot number 14973709 were implanted.
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: UNIVERS REVERS HUMERAL STEM, SIZE 8
• Common Device Name: SHOULDR PROSTH HEMI- HUM UNCEM
• 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: jared engle ; 8009337001
• MDR Report Key: 19605763
• Report Number: 1220246-2024-06409
• Device Sequence Number: 12390226
• Product Code: HSD
• UDI-Device Identifier: 00888867250406
• UDI-Public: 00888867250406
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K161782
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2025

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 Model Number: UNIVERS REVERS HUMERAL STEM, SIZE 8
• Device Catalogue Number: AR-9501-08P
• Device Lot Number: 22.03564
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2024
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2023
• 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