SMR Shoulder Finned Stem (REF 1304.15.170)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08033390000918), received between May 30, 2025 and May 30, 2025 — classified as 1 injury.

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

• InjuryMay 30, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2025, DUE TO LOOSENING. PATIENT UNDERWENT A PREVIOUS REVISION SURGERY WITH THE IMPLANT OF A REVERSE FOR FRACTURE (DATE UNKNOWN). THE FOLLOWING STEM WAS LOOSE AND WAS REMOVED: - SMR CEMENTLESS FINNED STEM (PART CODE 1304.15.170, LOT NUMBER 2114975, STERILIZATION 2100314). THE SURGEON PUT IN A LONG 16X150 REVISION STEM. THE OTHER COMPONENTS PREVIOUSLY IMPLANTED WERE LEFT IN SITU (EXCEPT THE HUMERAL STEM ABOVE MENTIONED, THE REVERSE TRAUMA BODY AND THE LINER): - SMR CONNECTOR SMALL R (PART CODE 1374.15.305, LOT NUMBER 2219451, STERILIZATION (B)(4)). - SMR METAL-BACK GLENOID SMALL R (PART CODE 1375.21.005, LOT NUMBER 2208559, STERILIZATION (B)(4)). - SMR ECCENT. GLENOSPHERE Ø 40MM (PART CODE 1376.09.041, LOT NUMBER 2214738, STERILIZATION (B)(4)). - SMR REVERSE FINNED HUMER. BODY (PART CODE 1352.15.050, LOT NUMBER 2010261, STERILIZATION (B)(4)). - SMR REVERSE LINER +3MM D.40MM (PART CODE 1365.50.815, LOT NUMBER 21AT106, STERILIZATION (B)(4)). PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2022. THE EVENT HAPPENED IN THE UNITED STATES.

  Patient problems: Joint Laxity

  MAUDE report 22113640 ↗