MAUDE Adverse Event Report: SHOULDER INNOVATIONS INSET 95 HUMERAL STEM

Model Number	2L1S060001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	02/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient underwent a successful total shoulder arthroplasty procedure.At the six month post procedure clinic visit, it was stated that the patient had symptoms suggestive a metal allergy, no other details were provided.The patient subsequently had an allergy test and the results found the patient to be "mildly reactive" to chromium.No other information was provided.

• Brand Name: INSET 95 HUMERAL STEM
• Common Device Name: INSET 95 HUMERAL STEM
• Manufacturer (Section D): SHOULDER INNOVATIONS; 1535 steele ave sw; suite b; grand rapids MI 49507
• Manufacturer (Section G): SHOULDER INNOVATIONS; 1535 steele ave sw; suite b; grand rapids MI 49507
• Manufacturer Contact: alyson newell ; 1535 steele ave sw; suite b; grand rapids, MI 49507 ; 4086670535
• MDR Report Key: 24840969
• Report Number: 3012544635-2026-00018
• Device Sequence Number: 21101459
• Product Code: MBF
• UDI-Device Identifier: B1132L1S0600010
• UDI-Public: B1132L1S0600010
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K241817
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/10/2026

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 Model Number: 2L1S060001
• Device Catalogue Number: 2L1S060001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 04/10/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: HUMERAL HEAD
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR
• Patient Sex: Female