MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS STEM, SIZE 11, CAP COATED; PROSTHESIS, SHOULDER, CEMENTED

Model Number	UNIVERS REVERS STEM, SIZE 11, CAP COATED
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Insufficient Information (4580)
Date of Event	12/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the invers shoulder prothesis was initially implanted on (b)(6) 2020.A crash on (b)(6) 2020, caused a periprosthetic fracture, which was treated conservatively.The fracture subsequently healed.The last images taken on (b)(6) 2022, showed that the implant was in the correct position.The x-rays taken on (b)(6) 2025, showed a fracture between the cup and the shaft.The implant was removed on (b)(6) 2025.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d6a, d6b, d9, g3, h3, h6 the complaint allegation was confirmed.One unpackaged ar-9501-11cpc, arthrex univers revers stem batch 19.02982, was received for evaluation.Visual inspection revealed that the returned stem exhibited scratches and dents.A possible fragment of screw threading was observed in one of the connector holes.Evaluation of another hole showed signs of cross-threading on the internal threads.A functional test cannot be performed due to the damage.The most likely cause of the reported failure is related to a patient-specific event.Directions for use dfu-0189-eu-01-eo - univers revers¿ shoulder prosthesis system j.Adverse effects 8.Loosening of the implant as a result of changed conditions in load transfer, respectively, fatigue wear and breakage of the cement bed and/or tissue reaction to the implant.Loosening is frequently a consequence of one or several of the above listed risk conditions, but can also be caused by inadequate anchoring technique (see below).10.Bone fractures as a result of one-sided overload or weakened bone substance.M.Precautions 3.Patient weight.An overweight patient may present additional risk.4.Extreme stress or strain resulting from work or sport related activity.5.Patients with increased risk of fractures due to repeated strain or trauma, or medical conditions that increase the patient's risk for trauma, including falls.

• Brand Name: UNIVERS REVERS STEM, SIZE 11, CAP COATED
• Common Device Name: PROSTHESIS, SHOULDER, CEMENTED
• 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: 23956323
• Report Number: 1220246-2026-00030
• Device Sequence Number: 18503658
• Product Code: PHX
• UDI-Device Identifier: 00888867061064
• UDI-Public: (01)00888867061064(11)200107(17)241130(10)19.02982
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K142863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2026

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: 11/30/2024
• Device Model Number: UNIVERS REVERS STEM, SIZE 11, CAP COATED
• Device Catalogue Number: AR-9501-11CPC
• Device Lot Number: 19.02982
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2020
• 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