SMR Shoulder Liner (REF 1377.50.005)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08033390002592), received between Mar 3, 2025 and May 26, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (3 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 26, 2026Break

  SHOULDER REVISION SURGERY DUE TO BREAKAGE OF THE LINER (PRODUCT CODE 1377.50.005, LOT: 17AT1FU). THE COMPONENTS LOST THEIR ARTICULATION, CAUSING METALLOSIS. REVISION SURGERY PERFORMED ON (B)(6) 2026. PREVIOUS SURGERY DATE IN NOT KNOWN. THIS EVENT OCCURRED IN ITALY.

  Patient problems: Metal Related Pathology

  MAUDE report 25275484 ↗
• InjuryMar 19, 2025Break; Degraded; Break; Degraded

  REVISION SURGERY PERFORMED ON (B)(6) 2025, DUE TO BASEPLATE FAILURE. GLENOID LINER HAS WORN OFF AND THE FOLLOWING COMPONENTS HAS BEEN REMOVED: SMR HUMERAL HEAD Ø44 MM (PART CODE 1322.09.440, LOT NUMBER 1412462, STERILIZATION (B)(4), SMR FINNED HUMERAL BODY (PART CODE 1350.15.110, LOT NUMBER 1412708, STERILIZATION (B)(4), SMR GLENOID PEG TT SMALL-R #M (PART CODE 1375.14.652, LOT NUMBER 1413948, STERILIZATION (B)(4). SMR GLENOID BASEPLATE SMALL-R (PART CODE 1375.15.605, LOT NUMBER 1410615, STERILIZATION (B)(4). LINER F. MET.BACK GLEN.SMALL-R (PART CODE 1377.50.005, LOT NUMBER 1406514, STERILIZATION (B)(4). THE COMPONENTS WERE CONVERTED TO HEMI ARTHROPLASTY. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2015. THE PATIENT IS A FEMALE, DATE OF BIRTH (B)(6)1961. THE EVENT HAPPENED IN THE UNITED STATES.

  Patient problems: Joint Impingement

  MAUDE report 21642241 ↗
• InjuryMar 3, 2025Break; Break

  SHOULDER REVISION SURGERY OF A SMR STEMLESS ANATOMIC IMPLANT PERFORMED ON (B)(6) 2025, DUE TO BREAKAGE OF THE LINER FOR METALBACK GLENOID SMALL-R (PRODUCT CODE 1377.50.005, LOT #22AT2XS - STER. 2300067). IT WAS REPORTED THAT THE PATIENT UNDERWENT A STEMLESS TOTAL SHOULDER SURGERY ON (B)(6) 2023 AND WENT TO THE HOSPITAL DUE TO DISCOMFORT IN (B)(6) 2024. AFTER SEEING THE X-RAY SHOWING THE HUMERAL HEAD ATTACHED TO THE METALBACK GLENOID, THE PROCEDURE WAS CHANGED FROM REVISION TO REVERSE. THE FOLLOWING COMPONENTS WERE EXPLANTED: LINER FOR METALBACK GLENOID SMALL-R (PRODUCT CODE 1377.50.005, LOT #22AT2XS - STER. 2300067). SMR HUMERAL HEAD Ø44 MM (PRODUCT CODE 1322.09.440, LOT #2212948 - STER. 2200196). SMR STEMLESS - NEUTRAL ADAPTOR (PRODUCT CODE 1335.15.200, LOT #2319374 - STER. 2300212). IT WAS REPORTED THAT THE METALBACK WAS FOUND TO BE FIRMLY FIXED, AND THE STEMLESS CORE WAS ALSO WELL FIXED TO THE HUMERUS. THE PATIENT REPORTED NOT HAVING FALLEN OR HIT HIS SHOULDER SINCE THE FIRST SURGERY. ACCORDING TO THE RECEIVED INFORMATION, THE PATIENT WAS COMPLIANT TO POST-OPERATIVE INDICATIONS. NO CLINICAL INFORMATION IS AVAILABLE. EVENT HAPPENED IN KOREA.

  Patient problems: Pain

  MAUDE report 21502846 ↗