MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS HUMERAL STEM, SIZE 6; SHOULDR PROSTH HEMI- HUM UNCEM

Model Number	UNIVERS REVERS HUMERAL STEM, SIZE 6
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/18/2023
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 5/19/2023, it was reported by a sales representative via email that an ar-9501-06p humeral stem, an ar-9502f-36cpc suture cup, an ar-9503s-03 humeral insert, an ar-9564-2436-lat glenosphere, an ar-9560-24 baseplate, an ar-9561-35s central screw, (2)ar-9563-28 peripheral screw, and (2) ar-9563-20 peripheral screw, were explanted during a revision shoulder arthroplasty surgery on (b)(6) 2023.On (b)(6) 2022, the patient underwent original surgery.Then on (b)(6) 2023, the patient started to experience pain.Radiographs appeared to show some radiolucent lines around the baseplate.The patient did not report any falls or notable events.The infection type has not been confirmed.During the revision surgery, an ar-9150-21 ca humeral head and an ar-9100-05p monoblock stem were implanted as functional antibiotic spacers.Both procedures were performed by the same surgeon but at different facilities.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint is confirmed based on the x-ray provided from the field.Consequently, 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 6
• 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: vik bajnath ; 8009337001
• MDR Report Key: 17111492
• Report Number: 1220246-2023-06894
• Device Sequence Number: 20394182
• Product Code: HSD
• UDI-Device Identifier: 00888867249264
• UDI-Public: 00888867249264
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K161782
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2025

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: 06/30/2026
• Device Model Number: UNIVERS REVERS HUMERAL STEM, SIZE 6
• Device Catalogue Number: AR-9501-06P
• Device Lot Number: 21.01621
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2023
• Supplement Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 06/12/2023
• Supplement Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2021
• 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