SMR System 1375.21.010Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08033390273350), received between Jan 29, 2026 and May 26, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 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, 2026Detachment of Device or Device Component; Patient Device Interaction Problem

  REVISION SURGERY PERFORMED ON (B)(6) 2026 BECAUSE OF GLENOID COMPONENTS FAILURE DUE TO BAD PLACEMENT. PREVIOUS SURGERY IS UNKNOWN, AS WELL AS COMPLETE PRODUCT INFORMATION OF ORIGINAL IMPLANT. DURING REVISION THE PRE-EXISTING METAL BACK GLENOID STD (PN 1375.21.010), GLENOSPHERE ECCENTRICAL DIA36MM (PN 1376.09.030) AND SMR REVERSE LINER STANDARD (PN 1360.50.810) WERE REMOVED AND THE ASSEMBLY WAS CONVERTED TO A HEMIARTHROPLASTY WITH AN ADAPTOR 36MM FOR REVERSE BODY (PN 1352.15.200) AND CTA HEAD DIA50MM (PN 1323.09.500). SURGERY WAS COMPLETED AS INTENDED. PATIENT IS FEMALE, DATE OF BIRTH (B)(6) 1951. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Joint Laxity

  MAUDE report 25278198 ↗
• InjuryMay 26, 2026Mechanical Problem

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2026 BECAUSE OF FAILURE OF REVERSE SHOULDER ASSEMBLY DUE TO MALALIGNMENT. PREVIOUS SURGERY IS UNKNOWN, AS WELL AS COMPLETE PRODUCT INFORMATION OF ORIGINAL PROSTHESIS. DURING REVISION, THE ORIGINAL METAL BACK (PN 1375.21.010) AND GLENOSPHERE DIA36MM (PN 1376.09.030) WERE REMOVED, AS WELL AS REVERSE LINER STANDARD (PN 1360.50.810), TO BE REPLACED WITH DIFFERENT MANUFACTURER REVERSE GLENOID ASSEMBLY. SURGERY WAS COMPLETED AS INTENDED. PATIENT IS FEMALE. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Insufficient Information

  MAUDE report 25275493 ↗
• InjuryJan 29, 2026Unstable; Patient Device Interaction Problem

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 DUE TO LOOSENING. THE GLENOID COMPONENT WAS LOOSE, CAUSING INSTABILITY. PREVIOUS SURGERY IS UNKNOWN, AS WELL AS COMPLETE PRODUCT INFORMATION OF ORIGINAL IMPLANT. DURING REVISION THE SURGEON OPTED TO TAKE OUT ALL GLENOID COMPONENTS: - SMR METAL-BACK GLENOID STD (PART NUMBER 1375.21.010), - SMR ECCENT. GLENOSPHERE Ø 40MM (PART NUMBER 1376.09.041), - TWO BONE SCREW Ø6,5 H.35MM (PART NUMBER 8420.15.040). AND REPLACED THE EXISTING SMR REVERSE HUMERAL BODY (PART NUMBER 1352.15.010) AND SMR REVERSE LINER +6MM D.40MM (PART NUMBER 1365.50.820) TO IMPROVE EXPOSURE OF THE GLENOID DURING SURGERY. SUBSEQUENTLY A DEPUY ENHANCE GLENOID BASEPLATE WAS IMPLANTED ALONG WITH A 40MM GLENOSPHERE, WHILE ON THE HUMERAL SIDE A NEW SMR HUMERAL BODY (PN 1352.15.010) WITH EXTENSION FOR HUMERAL REVERSE BODY (PN 1352.15.001) AND REVERSE LINER RETENTIVE +6MM DIA40MM (PN 1365.50.821) WERE IMPLANTED. SURGERY WAS COMPLETED AS INTENDED. PATIENT IS MALE, DATE OF BIRTH (B)(6) 1936. THE EVENT OCCURRED IN UNITED STATES.

  Patient problems: Joint Laxity; Loose body in joint

  MAUDE report 24210831 ↗