SMR Shoulder Glenosphere (REF 1374.09.121)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08033390123129), received between Jun 6, 2025 and Jun 16, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJun 16, 2026Unstable

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 DUE TO SHOULDER INSTABILITY. PATIENT UNDERWENT PRIMARY SURGERY FOR REVERSE TOTAL SHOULDER ARTHROPLASTY ON (B)(6) 2023 WITH THE FOLLOWING ASSEMBLY: FINNED STEM SHORT DIA 19MM (PN 1304.15.019, LOT 2302711, STERILIZATION (B)(4)). REVERSE HUMERAL BODY (PN 1352.15.010, LOT 2305346, STERILIZATION (B)(4)). REVERSE LINER STD DIA40 (PN 1365.50.810, LOT 22AT2GY, STERILIZATION (B)(4)). GLENOID PEG TT SMALL-R #MEDIUM (PN 1375.14.652, LOT 2300712, STERILIZATION (B)(4)). TT AUGMENTED BASEPLATE 7° S-R DIA27MM (PN 1375.15.507, LOT 2303113, STERILIZATION (B)(4)). CONNECTOR SMALL-R (PN 1374.15.305, LOT 2308047, STERILIZATION (B)(4)). GLENOSPHERE DIA40 (PN 1374.09.121, LOT 2305626, STERILIZATION (B)(4)). AFTER AROUND ONE YEAR THE CONSTRUCT BECAME UNSTABLE AND THE SURGEON REVISED THE PATIENT (HEREBY REPORTED) REMOVING THE ABOVE-MENTIONED CONNECTOR, GLENOSPHERE AND LINER TO IMPLANT A MORE LATERALIZED ASSEMBLY CONSISTING OF: LATERALIZED CONNECTOR +2MM SMALL-R (PN 1374.15.312, LOT 2011107, STERILIZATION (B)(4)). GLENOSPHERE DIA36MM (PN 1374.09.111, LOT 2407091, STERILIZATION (B)(4)). REVERSE LINER DIA36 +3MM (PN 1360.50.815, LOT 23AT253, STERILIZATION (B)(4))

  Patient problems: Joint Laxity

  MAUDE report 25519179 ↗
• InjuryFeb 25, 2026Mechanical Problem

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2026 DUE TO FAILURE OF GLENOID COMPONENTS. PREVIOUS SURGERY IS UNKNOWN, AS WELL AS COMPLETE PRODUCT INFORMATION OF ORIGINAL IMPLANT. DURING REVISION THE GLENOSPHERE (PART NUMBER: 1374.09.121) HAS BEEN REPLACED WITH A NEW ONE AND LATERALIZED WITH A SMALL/STD CONNECTOR LATERALIZED +2MM, AND THE REVERSE LINER (PART NUMBER: 1365.50.815) HAS BEEN REPLACED. SURGERY WAS COMPLETED AS INTENDED. THE PATIENT IS MALE, DATE OF BIRTH ON (B)(6) 1948. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24442717 ↗
• InjuryJan 30, 2026Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY WAS PERFORMED DUE TO SHOULDER DISLOCATION AND POSSIBLE INFECTION. PREVIOUS SURGERY IS UNKNOWN, AS WELL AS COMPLETE INFORMATION OF ORIGINAL IMPLANT. DURING REVISION THE SURGEON REMOVED THE REVERSE GLENOID COMPONENTS (GLENOSPHERE 40MM PN 1374.09.121, BASEPLATE AND SCREWS) AND REVERSE LINER FROM HUMERAL PART, AND IMPLANTED NEW REVERSE COMPONENT FROM OTHER MANUFACTURER TO RESTORE SHOULDER PROSTHETIC ASSEMBLY. SURGERY WAS COMPLETED AS INTENDED. PATIENT IS MALE, DATE OF BIRTH (B)(6) 1960. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Joint Dislocation; Medical device site infection

  MAUDE report 24219761 ↗
• InjuryJan 23, 2026Unstable

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 DUE TO SHOULDER INSTABILITY. PREVIOUS SURGERY IS UNKNOWN, AS WELL AS COMPLETE INFORMATION REGARDING ORIGINAL IMPLANT ASSEMBLY. DURING REVISION THE FOLLOWING PRE-EXISTING REVERSE COMPONENTS WERE EXPLANTED: SMR METAL BACK GLENOID SMALL (PART NUMBER: 1375.21.005). CONNECTOR SMALL (PART NUMBER: 1374.15.305). SMR REVERSE LINER +3MM D40MM (PART NUMBER: 1365.50.815). SMR GLENOSPHERE 40MM (PART NUMBER: 1374.09.121). PROSTHESIS WAS CONVERTED TO AN ANATOMIC CONFIGURATION IMPLANTING ADAPTOR 36MM FOR REVERSE BODY (PN: 1352.15.200) AND CTA HEAD (PN: 1323.09.500). SURGERY WAS COMPLETED AS INTENDED. PATIENT IS MALE, DATE OF BIRTH ON (B)(6) 1965. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Joint Laxity

  MAUDE report 24163049 ↗
• InjuryJan 23, 2026Unstable; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 DUE TO INFECTION AND INSTABILITY OF GLENOSPHERE CONNECTOR, GLENOSPHERE AND HUMERAL STEM. PREVIOUS SURGERY IS UNKNOWN, AS WELL AS COMPLETE PRODUCT INFORMATION OF ORIGINAL IMPLANT. DURING REVISION THE SURGEON EXPLANTED THE INVOLVED COMPONENTS ON THE GLENOID SIDE AND REPLACED THEM WITH NEW LATERALIZED CONNECTOR +2MM SMALL (PART NUMBER 1374.15.312), GLENOSPHERE 40MM (PART NUMBER 1374.09.121) AND A NEW REVERSE LINER RETENTIVE STD DIA40MM (PART NUMBER 1365.50.811) ON HUMERAL SIDE FOR RENEWAL REASONS. SURGERY WAS COMPLETED AS INTENDED. PATIENT IS MALE, DATE OF BIRTH (B)(6)1960. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Joint Laxity; Medical device site infection

  MAUDE report 24159384 ↗
• InjuryJan 2, 2026Device Dislodged or Dislocated

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 DUE TO SHOULDER DISLOCATION. PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2025 AND FOLLOWING SHOULDER PROSTHETIC COMPONENTS WERE IMPLANTED: SMR GLENOID PEG TT SMALL-R MEDIUM (PART NUMBER 1375.14652, LOT 2514349, STERILIZATION (B)(4), SMR TT AUGMENTED 360 BASEPLATE 15°, S-R, DIA27MM (PART NUMBER 1375.15.515, LOT 2425995, STERILIZATION (B)(4), SMR CONNECTOR LAT +2MM + SCREW SMALL-R (PART NUMBER 1374.15.312, LOT 2513794, STERILIZATION (B)(4), SMR GLENOSPHERE DIA 40MM (PART NUMBER 1374.09.121, LOT 2328003, STERILIZATION (B)(4), SMR FINNED STEM SHORT DIA 21MM (PART NUMBER 1304.15.021, LOT 2326100, STERILIZATION (B)(4), SMR FINNED REVERSE 140° HUMERAL BODY (PART NUMBER 1352.15.051, LOT 2014680, STERILIZATION (B)(4), SMR REVERSE LINER +6MM DIA40MM (PART NUMBER 1365.50.820, LOT 23AT489, STERILIZATION (B)(4). REPORTEDLY, PATIENT IS A CHRONIC DISLOCATOR WITH MEDICAL ISSUES. AS TROUBLESHOOTIN, THE SURGEON REMOVED PARTIAL HARDWARE (TT AUGMENTED BASEPLATE, GLENOID TT PEG, LATERALIZED CONNECTOR AND GLENOSPHERE) AND CONVERTED TO AN ANATOMIC CONFIGURATION WITH CTA HEAD DIA 54MM (PART NUMBER 1323.09.540) AND ITS ADAPTOR (1352.15.200) FOR STABILITY. SURGERY

  Patient problems: Joint Dislocation

  MAUDE report 23943025 ↗
• InjuryJul 25, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2025, DUE TO DISLOCATION, PATIENT DISLOCATED AND NEEDED TO BE LATERALIZED. THE FOLLOWING COMPONENTS WERE REMOVED AND REPLACED BY NEW ONES: - SMR REVERSE LINER RETENTIVE (PART CODE 1365.50.821, LOT NUMBER 24AT0Y0, STERILIZATION 2400221) - SMR GLENOSPHERE Ø 40MM (PART CODE 1374.09.121, LOT NUMBER 2407737, STERILIZATION 2400098) - SMR SMALL/STD CONNECTOR +2 (PART CODE 1374.15.322, LOT NUMBER 2205023, STERILIZATION 2200081) PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2025, REGISTERED AS INTERNAL COMPLAINT(B)(4) (AND REPORTED AS MFR. 3008021110-2025-00107). THE PATIENT IS A MALE, DATE OF BIRTH (B)(6) 1942. THE EVENT HAPPENED IN THE UNITED STATES.

  Patient problems: Joint Dislocation

  MAUDE report 22620878 ↗
• InjuryJun 6, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  REVISION SURGERY PERFORMED ON (B)(6) 2025, DUE TO LOOSENING. PATIENT PRESENTED WITH A LOOSE HUMERAL COMPONENT. THE FOLLOWING GLENOSPHERE WAS REMOVED AND REPLACED BY A NEW GLENOSPHERE (DIAMETER 42 MM): - SMR GLENOSPHERE DIA. 40MM (PART CODE 1374.09.121, LOT NUMBER 2201768, STERILIZATION (B)(4)). THE DATE OF PREVIOUS SURGERY IS UNKNOWN. THE PATIENT IS A MALE, DATE OF BIRTH (B)(6) 1953. THE EVENT HAPPENED IN THE UNITED STATES.

  Patient problems: Joint Laxity

  MAUDE report 22159543 ↗

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