SMR System 1377.50.020Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08033390272704), received between Jan 30, 2026 and May 4, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• InjuryMay 4, 2026Detachment of Device or Device Component

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2026 DUE TO DISASSEMBLY OF COMPONENTS AND METALLOSIS. PREVIOUS SURGERY IS UNKNOWN, AS WELL AS COMPLETE PRODUCT INFORMATION OF ORIGINAL IMPLANT. DURING REVISION, THE PRE-EXISTING LINER FOR METAL BACK GLENOID SMALL (PN 1377.50.020) WAS FOUND LOOSE FROM THE SMR METAL-BACK GLENOID SMALL (PN 1375.21.020) AND FLOATING IN THE JOINT, CAUSING METAL ON METAL FRICTION AND THEREFORE SEVERE METALLOSIS. SURGEON REMOVED ALL THE GLENOID COMPONENTS, AS WELL AS THE PRE-EXISTING SMR HUMERAL HEAD Ø50 MM (PN 1322.09.500) AND ADAPTOR TAPER (PN 1330.15.274) AND RE-IMPLANTED A NEW TAPER AND HEAD ON THE HUMERAL SIDE TO RESTORE SHOULDER FUNCTIONALITY WITH A HEMI ARTHROPLASTY. SURGERY WAS COMPLETED AS INTENDED. PATIENT IS MALE, DATE OF BIRTH (B)(6)1960. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Loose body in joint; Metal Related Pathology

  MAUDE report 25067102 ↗
• InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem

  A SHOULDER REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 DUE TO CUFF FAILURE, COMPONENT WEAR, LOSS OF RANGE OF MOTION, AND PAIN. THE COMPLAINT SOURCE ALSO REPORTED THAT CUFF FAILURE CAUSED SUPERIOR MIGRATION OF THE HUMERAL HEAD, WITH SIGNIFICANT WEAR THROUGH THE LINER. THE LINER WAS STILL ENGAGED IN THE METAL-BACK COMPONENT. AS A RESULT, THE SURGEON DECIDED TO REMOVE THE ANATOMIC COMPONENTS AND CONVERT THE IMPLANT TO A REVERSE CONFIGURATION. THE FOLLOWING DEVICES WERE EXPLANTED: · SMR HUMERAL HEAD Ø50 MM (PRODUCT CODE: 1322.09.500, LOT NUMBER: UNKNOWN). · NEUTRAL ADAPTOR TAPER STANDARD (PRODUCT CODE: 1330.15.270, LOT NUMBER: UNKNOWN). · SMR FINNED HUMERAL BODY (PRODUCT CODE: 1350.15.110, LOT NUMBER: UNKNOWN). · LINER F. MET.BACK GLEN. SMALL (PRODUCT CODE: 1377.50.020, LOT NUMBER: UNKNOWN). · METAL-BACK GLENOID SMALL (PRODUCT CODE: 1375.20.020, LOT NUMBER: UNKNOWN). THE INITIAL SHOULDER IMPLANTATION SURGERY WAS PERFORMED ON (B)(6) 2009. THE PATIENT WAS FEMALE AND WAS 88 YEARS OLD AT THE TIME OF THE REVISION SURGERY. EVENT HAPPENED IN AUSTRALIA.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 24223086 ↗