Shoulder Innovations InSet 95 Humeral Stem 8x95mmRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI B1132L1S0800010), received between Mar 9, 2026 and Mar 13, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE SHOULDER ARTHROPLASTY PROCEDURE, WHILE RETRACTING THE SURGEON HEARD A "SMALL CRACK" AND IT WAS NOTED THAT THE GREATER TUBEROSITY WAS FRACTURED. THE FRACUTRE DID NOT EXTEND INTO THE CALCAR OR DISTALLY. THE GREATER TUBEROSITY FRAGMENT WAS REMOVED AND THE PATIENT WAS TO BE MONITORED AT CLINIC VISITS USING X-RAYS. THE SURGEON DID NOT RELATE THE EVENT TO THE DEVICE BUT TO THE PROCEDURE. THERE WAS NO REPORTED CLINICAL CONSEQUENCE TO THE PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Bone Fracture(s)

  MAUDE report 24595850 ↗
• InjuryMar 9, 2026Loosening of Implant Not Related to Bone-Ingrowth

  APPROXIMATELY 1 MONTH AFTER SHOULDER ARTHROPLASTY, TH PATIENT REPORTED IN THE WEEK LEADING UP TO A ROUTINE CLINIC VISIT, FEELING A SHARP PAIN AND SHIFT IN THE SURGICAL SHOULDER WHILE SITTING IN A CHAIR. AN X-RAY TAKEN AT THE CLINIC VISIT SHOWED AN ABNORMALITY THAT THE SURGEON DETERMINED WAS IMPLANT LOOSENING ON THE HUMERAL SIDE. THE PATIENT UNDERWENT REVISION SURGERY TO ADDRESS THE ISSUE WITH NO REPORTED CLINICAL CONSEQUENCE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24549344 ↗