SMR Shoulder Glenosphere (REF 1376.09.041)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08033390123112), received between Aug 22, 2025 and Mar 19, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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. How this data works · Data updated Oct 13, 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.

• InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2026 DUE TO INFECTION. PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2025 AND FOLLOWING COMPONENTS WERE IMPLANTED: - REVERSE LINER (PN 1365.50.810, LOT. 23AT07N, STER. (B)(4)) - TT AUGMENTED 360 BASEPLATES (PN 1375.15.515, LOT. 2515952, STER. (B)(4)) - 140° HUMERAL BODY (PN 1352.15.051, LOT. 2523962, STER. (B)(4)) - GLENOSPHERE ECCENTRICAL DIA 40MM (PN 1376.09.041, LOT. 2022366, STER. (B)(4)) - CONNECTOR LAT + 2MM + SCREW (PN 1374.15.312, LOT. 2525197, STER. (B)(4)) - FINNED STEM (PN 1304.15.022, LOT. 2327598, STER. (B)(4)) - GLENOID PEG TT (PN 1375.14.652) - BONE SCREW (PN 8420.15.020) - BONE SCREW (PN 8420.15.010) DURING REVISION ALMOST ALL PRE-EXISTING COMPONENTS WERE REMOVED AND NEW RETENTIVE LINER +3MM (PN 1361.50.810), TT AUGMENTED 360 BASEPLATE (PN1375.15.565), 140° HUMERAL BODY (PN 1352.15.051), CONNECTOR LAT 4MM + SCREW (PN1374.15.314), GLENOSPHERE DIA 36 MM (PN 1374.09.111) AND BONE SCREWS (PN 8420.15.010, PN 8420.15.020, 8420.15.030) WERE IMPLANTED. WOUND WAS IRRIGATED AND A TISSUE SAMPLE WAS SENT FOR ANALYSIS. SURGERY WAS COMPLETED AS INTENDED. PATIENT IS MALE, DATE OF BIRTH (B)(6) 1958. EVENT OCCURRED IN UNITED STATES.

  Patient problems: Medical device site infection

  MAUDE report 24638409 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 IN ORDER TO TREAT PATIENT FOR POSSIBLE INFECTION. PREVIOUS SURGERY IS UNKNOWN, AS WELL AS COMPLETE PRODUCT INFORMATION OF ORIGINAL IMPLANT. DURING REVISION IRRIGATION AND DEBRIDMENT WAS PERFORMED, AND ORIGINAL COMPONENTS WERE REPLACED WITH NEW ONES: - SMR ECCENT. GLENOSPHERE Ø 40MM (PART NUMBER 1376.09.041), - SMR SMALL/STD CONNECTOR +4 (PART NUMBER 1374.15.324), - SMR REVERSE HUMERAL BODY SHORT (PART NUMBER 1352.15.005), - SMR HUMERAL EXTENSION + 9 MM (PART NUMBER 1352.15.001), - SMR REVERSE LINER RETENTIVE (PART NUMBER 1365.50.816). SURGERY HAS BEEN COMPLETED AS INTENDED. THE PATIENT IS MALE, DATE OF BIRTH (B)(6) 1980. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Medical device site infection

  MAUDE report 24210833 ↗
• InjurySep 18, 2025Unstable; Unstable

  REVISION SURGERY PERFORMED ON (B)(6) 2025, DUE TO INSTABILITY. PATIENT UNDERWENT A REVERSE TOTAL SHOULDER 2 MONTHS AGO WITH LIMA SMR. PATIENT BEGAN EXPERIENCING INSTABILITY AND RETURNED TO OR FOR INCREASED GLENOSPHERE LATERALIZATION AND POLY SWAP. THE FOLLOWING COMPONENTS WERE REMOVED AND REPLACED BY NEW ONES: REVERSE LINER +3 MM D.40 MM (PART CODE: 1365.54.815, LOT NUMBER: 23AT3Z2, STERILIZATION: 2400028). SMR ECCENT. GLENOSPHERE Ø 40MM (PART CODE: 1376.09.041, LOT NUMBER: 2501637, STERILIZATION: 2500038). SMR SMALL/STD CONNECTOR +2 (PART CODE: 1374.15.322, LOT NUMBER: 2506233, STERILIZATION: 2500072). PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2025. THE PATIENT IS A MALE, DATE OF BIRTH ON (B)(6) 1961. THE EVENT HAPPENED IN THE UNITED STATES.

  Patient problems: Joint Laxity

  MAUDE report 23084383 ↗
• InjuryAug 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION SURGERY PERFORMED ON (B)(6) 2025, DUE TO IMPLANT DISLOCATION. PATIENT WAS IN A SKILLED NURSING FACILITY AND A PROVIDER PULLED ON HIS ARM AND RIPPED OUT THE BASEPLATE. WHEN THE SURGEON REVISED HIM, THE ENTIRE BASEPLATE, SCREWS AND GLENOSPHERE ALL CAME OUT EASILY, SO THE SURGEON WENT WITH A LARGER BASEPLATE AND LONGER SCREWS AND REPLACED THE POLY IN THE REVISION. THE FOLLOWING COMPONENTS WERE REMOVED AND REPLACED BY NEW ONES: - SMR METAL-BACK GLENOID STD (PART CODE 1375.21.010, LOT NUMBER 2408266, STERILIZATION (B)(4)). - SMR ECCENT. GLENOSPHERE Ø 40MM (PART CODE 1376.09.041, LOT NUMBER 2405201, STERILIZATION (B)(4)). - SMR CONNECTOR SMALL STD (PART CODE 1374.15.310, LOT NUMBER 2426988, STERILIZATION (B)(4)). - SMR REVERSE LINER RETENTIVE (PART CODE 1365.50.821, LOT NUMBER 24AT0Y0, STERILIZATION (B)(4)). PREVIOUS SURGERY PERFORMED ON (B)(6) 2025. THE SUBSEQUENT REVISION SURGERY (PERFORMED ON (B)(6) 2025) WAS REGISTERED AS COMPLAINT (B)(4) (REPORTED WITH MFR. 3008021110-2025-00098). THE PATIENT IS A MALE, DATE OF BIRTH (B)(6). THE EVENT HAPPENED IN THE UNITED STATES.

  Patient problems: Joint Dislocation

  MAUDE report 22872907 ↗

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