SMR System 1350.15.030Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08033390272506), received between Mar 17, 2025 and Mar 17, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K100858); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 17, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  REVISION SURGERY PERFORMED ON (B)(6) 2025, DUE TO GLENOID LOOSENING, BONE LOSS AND POOR BONE QUALITY. THE FOLLOWING COMPONENTS WERE REMOVED: SMR TRAUMA HUM. BODY# SHORT (PART NUMBER: 1350.15.030, LOT NUMBER: 2017188, STERILIZATION: 2000339). SMR HUMERAL HEAD Ø42 MM (PART NUMBER: 1322.09.420, LOT NUMBER: 1400754, STERILIZATION: 2100055). SMR ECC. ADAPTOR TAPER STANDARD (PART NUMBER: 1330.15.274, LOT NUMBER: 2124614, STERILIZATION: 2200002). THE PATIENT PREVIOUSLY HAD A TOTAL SHOULDER ARTHROPLASTY WITH LIMA COMPONENTS (SMR STEM, TRAUMA BODY, ECCENTRIC ADAPTER, HUMERAL HEAD, AND 3-PEGGED CEMENTED POLY), THOUGH THE INITIAL SURGERY DATE IS UNKNOWN. ON (B)(6) 2024, THE PATIENT UNDERWENT A REVISION PROCEDURE FOR GLENOID LOOSENING. DURING THE ON (B)(6) SURGERY, THE SURGEON ATTEMPTED TO COMPLETE THE SECOND PHASE OF THE REVISION. THE HUMERAL STEM, BODY, AND HEAD WERE REMOVED. HOWEVER, WHEN TRYING TO IMPLANT THE BASEPLATE FOR A REVERSE SHOULDER REPLACEMENT, THE SOFT GLENOID BONE CRACKED. TO ADDRESS THIS, THE SURGEON DECIDED TO REINFORCE THE GLENOID WITH BONE GRAFT AND PROCEEDED BY PLACING AN ADAPTER AND HUMERAL HEAD ONTO THE REVERSE BODY, CONVERTING IT INTO A HEMIARTHROPLASTY. THE PATIENT IS

  Patient problems: Inadequate Osseointegration

  MAUDE report 21620230 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K100858. One submission often covers many models, so check the product and lot details in each record.

• Z-2539-2015 · Aug 14, 2015 · Terminated
  SMR Shoulder/Spalla Trial Humeral Head diameter .42 mm, REF 9013.22.425; SMR Shoulder/Spalla Trial Humeral Head diameter .44 mm, REF 9013.22.445; SMR Shoulder/Spalla Trial Humeral
• Z-2540-2015 · Aug 14, 2015 · Terminated
  SMR Shoulder/Spalla Trial Heads ECC .4 mm Adaptor, REF 9013.30.021; SMR Shoulder/Spalla Trial Heads ECC .8 mm Adaptor, REF 9013.30.031; for use in shoulder implant surgery.