MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS HUMERAL STEM, 5MM; SHOULDR PROSTH HEMI- HUM UNCEM

Model Number	UNIVERS REVERS HUMERAL STEM, 5MM
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On 3/22/2023, it was reported by a sales representative via email that a revision shoulder arthroplasty procedure took place on (b)(6) 2023 due to an infection.The surgeon removed an ar-9580-2420 univers revers modular glenoid system augmented baseplate, an ar-9582-20 modular post for augmented mgs baseplate, an ar-9562-32nl univers revers modular glenoid system, peripheral screw, non-locking 4.5 x 32 mm, an ar-9562-24nl univers revers modular glenoid system, peripheral screw, non-locking 4.5 x 24 mm, an ar-9563-20 univers revers modular glenoid system, peripheral screw, locking 5.5 x 20 mm, an ar-9563-16 univers revers modular glenoid system, peripheral screw, locking 5.5 x 16 mm, an ar-9564-2436-lat arthrex univers revers modular glenoid system glenosphere, an ar-9503s-06 arthrex univers revers humeral insert, an ar-9502f-36cpc arthrex univers revers suture cup, and an ar-9501-05p univers revers humeral stem.Additional information received on 3/23/2023: the original procedure occurred on (b)(6) 2021.About ten months later, the patient started to experience symptoms of infection.A culture was taken off the infected areas, but results are still pending.The same surgeon at the same facility performed both procedures.All the parts implanted during the original procedure on (b)(6) 2021 were explanted during the revision surgery on (b)(6) 2023.The patient is stable and was discharged from the hospital on (b)(6) 2023.
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.
Additional Manufacturer Narrative
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, 5MM
• 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: 16762610
• Report Number: 1220246-2023-06555
• Device Sequence Number: 14218999
• Product Code: HSD
• UDI-Device Identifier: 00888867247628
• UDI-Public: 00888867247628
• 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: 2021
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2024

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, 5MM
• Device Catalogue Number: AR-9501-05P
• Device Lot Number: 20.02978
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2023
• Supplement Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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