Shoulder Innovations Humeral Short Stem System 28mm x 6mmRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI B1132N2SN062800), received between Mar 13, 2026 and Mar 16, 2026 — classified as 2 injuries.

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. How this data works · Data updated Oct 13, 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 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AT A CLINIC VISIT APPROXIMATELY SIX MONTHS AFTER A SUCCESSFUL TOTAL SHOULDER ARTHROPLASTY, THE PATIENT REPORTED PAIN IN THE ANTERIOR ASPECT OF THE SHOULDER CONSISTENT WITH THE LOCATION OF THE BICEPS TENODESIS. THE SURGEON GAVE THE PATIENT A STEROID INJECTION INTO THE SHOULDER AND REPORTED THAT THE EVENT WAS POSSIBLY THE DEVICE AND THE PROCEDURE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Loss of Range of Motion

  MAUDE report 24607649 ↗
• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A SUCCESSFUL REVERSE SHOULDER ARTHROPLASTY AND THERE WERE NO ISSUES AT THE FIRST ROUTINE CLINIC VISIT. AT THE SECOND VISIT AT SIX WEEKS POST PROCEDURE, THE PATIENT REPORTED INCREASED PAIN AND BRUSING ON THE SHOULDER WITHOUT ANY TRAUMA. X-RAYS SHOWED THAT THE IMPLANTS WERE STABLE AND ULTRASOUND WAS PERFORMED AND THE SUBSCAPULARIS TENDON APPEARED TO BE INTACT. A CT SCAN WAS PERFORMED A WEEK LATER AND THIS DID NOT REVEAL ANY BONY ABNORMALITIES OR FRACTURES. ASPIRATION WAS ATTEMPTED AND 2CC OF SEROUS FLUID WAS REMOVED. AN MRI REVEALED A HEMATOMA IN DELTOID. 900 CC WAS ASPIRATED. A DECISION WAS MADE TO PERFORM EVACUATION OF THE HEMATOMA AND THIS WAS CONDUCTION APPROXIMATELY TWO MONTHS POST PROCEDURE ALONG WITH IRRIGATION AND DEBRIDEMENT. THE PATIENT RETURNED TO CLINICAL APPROXIMATELY SIX WEEKS AFTER THE HEMATOMA EVACUATION AND REPORTED LESS PAIN AND X-RAY SHOWED EVERYTHING WAS STABLE. THE PHYSICIAN ASSIGNED A POSSIBLE RELATIONSHIP TO THE DEVICE AND PROCEDURE.

  Patient problems: Hematoma

  MAUDE report 24593944 ↗