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	Patient Device Interaction Problem (4001); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Bacterial Infection (1735); Pain (1994); Loss of Range of Motion (2032)
Date of Event	12/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On 7/24/2024, a clindex notification was received indicating that a patient listed on the shoulder arthroplasty registry has been experiencing ongoing and unchanged issues.The patient has experienced increased pain in the target shoulder and a decline in range of motion and strength over several months.A ct arthrogram results from 1/28/24 were inconclusive, noting possible baseplate etiology.Lab work, performed on 1/28/2024, has ruled out infection.The symptoms have been managed with sling use, concomitant medication, and activity modification.The patient is to be scheduled for an exploratory surgery for diagnosis, with likely revision.It is unknown if these issues are related to the univers revers apex devices implanted on (b)(6) 2023.The arthrex device implanted in the patient are an ar-9560-24-2 arthrex univers revers modular glenoid system modulas baseplate 24 mm +2 lat, an ar-9503s-06 arthrex univers revers humeral insert small / 36 / +6, an ar-9561-25s univers revers modular glenoid system, central screw, modular 25 mm, an ar-9563-24 univers revers modular glenoid system, peripheral screw, locking 5.5 x 24 mm, an ar-9563-20 univers revers modular glenoid system, peripheral screw, locking 5.5 x 20 mm, two ar-9563-16 univers revers modular glenoid system, peripheral screw, locking 5.5 x 16 mm, an ar-9502f-36cpc arthrex univers revers suture cup, 36, an ar-9501-05p univers revers humeral stem size 5 135° modular, and an arthrex univers revers modular glenoid system glenosphere.The patient was scheduled for exploratory surgery for diagnosis, with likely revision in (b)(6) 2024, however, the patient canceled due to other life events.The patient has not rescheduled.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: b5, 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.
Event or Problem Description
Additional information received on 5/14/2025: the revision surgery was rescheduled per patient request to (b)(6) 2025.It was later rescheduled to (b)(6) 2025 due to surgeon availability.And then, rescheduled again per patient request to (b)(6) 2025.No further information was provided.
Additional Manufacturer Narrative
Additional information: b5, d6a, d6b, 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.
Event or Problem Description
Additional information received on 8/8/2025: on (b)(6) 2025, the patient underwent stage 1 of a planned two-stage revision arthroplasty, which included placement of an antibiotic spacer.The procedure was performed due to suspected cutibacterium acnes infection, resulting in loosening of the baseplate.Additional information was received on 08/19/2025: it was confirmed that the patient underwent revision surgery on (b)(6) 2025, during which all implants placed on (b)(6) 2023 were explanted.

• 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: jared engle ; 8009337001
• MDR Report Key: 20000452
• Report Number: 1220246-2024-07210
• Device Sequence Number: 11981309
• Product Code: HSD
• UDI-Device Identifier: 00888867247628
• UDI-Public: 00888867247628
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K161782
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Study
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/26/2025

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, 5MM
• Device Catalogue Number: AR-9501-05P
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2024
• Supplement Date Received by Manufacturer: 06/09/2025; 08/08/2025
• Initial Report FDA Received Date: 08/20/2024
• Supplement Report FDA Received Date: 06/10/2025; 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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