SMR System 1374.09.111Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08033390272230), received between Jan 23, 2026 and Jun 16, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Unstable” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K163397); 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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 16, 2026Unstable; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2026 DUE TO SHOULDER PAIN AND INSTABILITY. PATIENT UNDERWENT ORIGINAL SURGERY ON OCTOBER 17TH 2025 WHEN THE FOLLOWING REVERSE PROSTHESIS WAS IMPLANTED: FINNED STEM SHORT DIA 15 (PN 1304.15.015), 140° HUMERAL REVERSE BODY (PN 1352.15.011). REVERSE LINER DIA36MM +3MM (PN 1360.54.815, LOT 24AT62M, STERILIZATION 2500098). METAL-BACK GLENOID SMALL-R (PN 1375.21.005). CONNECTOR+SCREW SMALL-R (PN 1374.15.305, LOT 2520843, STERILIZATION 2500162). GLENOPHERE DIA 36MM (PN 1374.09.111, LOT 2519758, STERILIZATION 2500154). DURING REVISION THE ABOVE MENTIONED LINER, GLENOSPHERE AND CONNECTOR WERE REMOVED AND REPLACED WITH A NEW CONNECTOR, AN ECCENTRICAL GLENOSPHERE DIA36MM (PN 1376.09.031) IN ORDER TO GIVE BETTER RANGE OF MOTION AND DECEASED CHANCES OF ANTERIOR IMPINGEMENT, AND A REVERSE LINER STANDARD (PN 1360.54.810) TO MAKE UP FOR 4MM ECCENTRICITY OF THE GLENOSPHERE. SURGERY WAS COMPLETED AS INTENDED. PATIENT IS FEMALE, DATE OF BIRTH (B)(6) 1951. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Implant Pain

  MAUDE report 25519178 ↗
• InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY OCCURRED ON (B)(6) 2026 AS PATIENT PRESENTED POST-OP PAIN. DURING REVISION THE SURGEON REMOVED AND REPLACED FOLLOWING PRE-EXISTING COMPONENTS: - SMR CEMENTLESS FINNED STEM (PN 1304.15.150). - SMR REVERSE HUMERAL BODY (PN 1352.15.010). - SMR REVERSE LINER STANDARD (PN 1360.50.810). - SMR GLENOSPHERE Ø 36MM (PN 1374.09.111). - SMR CONNECTOR SMALL R (PN 1374.15.305). SURGERY WAS COMPLETED AS INTENDED. PATIENT IS MALE, DATE OF BIRTH (B)(6) 1947. EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Implant Pain

  MAUDE report 24638410 ↗
• InjuryJan 26, 2026Patient Device Interaction Problem

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 DUE TO FAILURE OF GLENOID COMPONENTS. PREVIOUS SURGERY IS UNKNOWN, AS WELL AS COMPLETE PRODUCT INFORMATION. DURING REVISION THE PRE-EXISTING SMR GLENOSPHERE Ø 36MM (PART NUMBER 1374.09.111) AND SMR SMALL-R CONNECTOR +2 (PART NUMBER 1374.15.312) WERE REMOVED AND REPLACED WITH NEW ONES. SURGERY WAS COMPLETED AS INTENDED. PATIENT IS FEMALE, DATE OF BIRTH (B)(6)1947. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24178570 ↗
• InjuryJan 23, 2026Unstable

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 DUE TO INSTABILITY. PREVIOUS SURGERY WAS A REVERSE TOTAL SHOULDER ARTHROPLASTY FOR A FRACTURE, AT UNKNOWN DATE. NO COMPLETE INFORMATION REGARDING ORIGINAL IMPLANT HAS BEEN PROVIDED EITHER. PATIENT DEVELOPED SHOULDER LAXITY AFTER PREVIOUS SURGERY AND NEEDED REVISION OF THE IMPLANT. SURGEON REPLACED PRE-EXISTING COMPONENTS WITH NEW LATERALIZED +4MM CONNECTOR (PART NUMBER 1374.15.315), ECCENTRICAL GLENOSPHERE 36MM (PART NUMBER 1376.09.031), REVERSE HUMERAL BODY (PART NUMBER 1351.15.010) AND REVERSE LINER +6MM (PART NUMBER 1360.50.820). SURGERY WAS COMPLETED AS INTENDED. PATIENT IS FEMALE, DATE OF BIRTH (B)(6) 1952. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Joint Laxity

  MAUDE report 24159385 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K163397. One submission often covers many models, so check the product and lot details in each record.

• Z-1317-2023 · Feb 21, 2023 · Open, Classified
  SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210