SMR Shoulder Liner (REF 1365.50.820)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08033390102940), received between Aug 6, 2024 and Jul 2, 2026 — classified as 7 injuries.

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

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJul 2, 2026Insufficient Device Problem Information

  SHOULDER REVISION SURGERY HAS BEEN PERFORMED ON (B)(6), 2026, DUE TO FAILURE OF GLENOID COMPONENTS. PREVIOUS SURGERY OCCURRED ON (B)(6), 2024, WHEN A REVERSE CONFIGURATION CONSISTING OF BOTH LIMACORPORATE AND ANOTHER MANUFACTURER COMPONENTS WERE IMPLANTED. DURING THE REVISION SURGERY HEREBY REPORTED, THE PRE-EXISTING REVERSE SHOULDER CONFIGURATION WAS CONVERTED TO A HEMIARTHROPLASTY CONFIGURATION, DUE TO FAILURE OF THE GLENOID COMPONENTS PRODUCED BY THE OTHER MANUFACTURER. THE PREVIOUSLY IMPLANTED COMPONENTS, INCLUDING THE SMR REVERSE LINER +6 MM D.40 MM (PN 1365.50.820, LOT. 23AT2PJ, STER. 2400073), WERE EXPLANTED AND FOLLOWING COMPONENTS WERE SUBSEQUENTLY IMPLANTED: · SMR FINNED STEM, DIAMETER 19 MM, LENGTH 80 MM (PN 1304.15.190); · SMR 140° REVERSE HUMERAL BODY (PN 1352.15.011); · SMR ADAPTER 36 MM FOR REVERSE BODY (PN 1352.15.200); · CTA HEAD, DIAMETER 54 MM (PN 1323.09.540). THE PROCEDURE WAS COMPLETED AS INTENDED. THE PATIENT IS FEMALE, DATE OF BIRTH (B)(6) 1963. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Insufficient Information

  MAUDE report 25687434 ↗
• InjuryMay 18, 2026Device Dislodged or Dislocated

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2026 DUE TO SHOULDER DISLOCATION. PREVIOUS SURGERY OCCURRED ON (B)(6) 2023 FOR A REVERSE TOTAL SHOULDER ARTHROPLASTY, WITH FOLLOWING COMPONENTS: - SMR TT BASEPLATE SMALL-R (PN 1375.15.605), - SMR GLENOID PEG TT SMALL-R #MEDIUM (PN 1375.14.652), - CONNECTOR LAR +2MM SMALL-R (PN 1374.15.312), - GLENOSPHERE DIA40MM (PN 1374.09.121, LOT 2213444, STERILIZATION (B)(4)), - FINNED STEM SHORT DIA25MM (PN 1304.15.025), - 140° REVERSE HUMERAL BODY (PN 1352.15.011). - REVERSE LINER +6MM DIA40MM (PN 1365.50.820, LOT 22AT0WC, STERILIZATION (B)(4)). AROUND 3 YEARS AFTER PREVIOUS SURGERY, PATIENT DISLOCATED. PRE-EXISTING CONNECTOR, GLENOSPHERE, REVERSE HUMERAL BODY AND LINER WERE REMOVED AND REPLACED WITH A MORE LATERALIZED AND THICK ASSEMBLY CONSISTING OF: - CONNECTOR LAT +4MM (PN 1374.15.314), - GLENOSPHERE ECCENTRICAL DIA 40MM (PN 1376.09.041), - 140° REVERSE HUMERAL BODY (PN 1352.15.011), - EXTENSION FOR HUMERAL REVERSE BODY (PN 1352.15.001), - REVERSE LINER +6MM DIA40MM (PN 1365.50.820). SURGERY WAS COMPLETED AS INTENDED. PATIENT IS MALE, DATE OF BIRTH (B)(6) 1953. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Joint Dislocation

  MAUDE report 25200752 ↗
• InjuryMay 11, 2026Detachment of Device or Device Component; Device Dislodged or Dislocated

  REVISION SURGERY HAS BEEN PERFORMED ON (B)(6) 2026, DUE TO LOOSENING OF JOINT AND DISLOCATION. DURING THE REVISION SURGERY PRE-EXISTING SMR REVERSE LINER +6MM DIA.40MM (PN 1365.50.820, LOT. 24AT3VE) HAS BEEN EXPLANTED AND REPLACED WITH SMR REVERSE LINER RETENTIVE +6MM DIA. 40MM (PN 1365.50.821). SURGERY HAS BEEN COMPLETED AS INTENDED. PREVIOUS SURGERY OCCURRED ON (B)(6) 2026. PATIENT DATE OF BIRTH IS (B)(6) 1953. EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Joint Dislocation

  MAUDE report 25134380 ↗
• InjuryMar 6, 2026Detachment of Device or Device Component

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2026 DUE TO DISASSEMBLY OF REVERSE LINER. PREVIOUS SURGERY OCCURRED ON DECEMBER 30TH 2025 WHEN THE FOLLOWING SMR REVERSE CONFIGURATION WAS IMPLANTED: - SMR CONNECTOR SMALL STD (PART NUMBER 1374.15.310, LOT 2500908, STERILIZATION (B)(4)), - SMR GLENOSPHERE Ø 40MM (PART NUMBER 1374.09.121, LOT 2501638, STERILIZATION (B)(4)), - SMR REVERSE HUMERAL BODY SHORT (PART NUMBER 1352.15.005, LOT 2507908, STERILIZATION (B)(4)), - SMR REVERSE LINER +6MM D.40MM (PART NUMBER 1365.50.820, LOT 24AT3VE, STERILIZATION (B)(4)). DURING REVISION THE ABOVE-MENTIONED LINER WAS REMOVED AND REPLACED WITH A NEW THINNER REVERSE LINER +3MM DIA40MM (PN 1365.50.815). SURGERY WAS COMPLETED AS INTENDED. THE PATIENT IS MALE, DATE OF BIRTH (B)(6) 1960. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Insufficient Information

  MAUDE report 24531027 ↗
• InjuryFeb 12, 2026Device Dislodged or Dislocated

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 BECAUSE PATIENT DISLOCATED. PREVIOUS SURGERY IS UNKNOWN, AS WELL AS COMPLETE INFORMATION OF ORIGINAL ASSEMBLY. DURING REVISION THE SURGEON REMOVED THE PRE-EXISTING SMR REVERSE LINER +6MM D.40MM (PN 1365.50.820) AND IMPLANTED AN EXTENSION FOR HUMERAL REVERSE BODY (PN 1352.15.001) AND A REVERSE LINER +6MM DIA40MM (PN 1365.54.820). SURGERY WAS COMPLETED AS INTENDED TO RESTORE SHOULDER FUNCTIONALITY. PATIENT IS MALE, DATE OF BIRTH (B)(6) 1964. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Joint Dislocation

  MAUDE report 24322377 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY PERFORMED ON (B)(6) 2025 DUE TO GLENOSPHERE FAILURE. REPORTEDLY, ORIGINAL IMPLANT WAS A REVERSE CONFIGURATION COMBINING ZIMMERBIOMET VRS ON THE GLENOID SIDE AND SMR COMPONENTS ON THE HUMERAL SIDE. PREVIOUS SURGERY IS UNKNOWN, AS WELL AS COMPLETE PRODUCT INFORMATION OR ORIGINAL COMPONENTS. DURING REVISION THE SURGEON REMOVED THE PRE-EXISTING REVERSE LINER +6MM DIA40MM (PART NUMBER 1365.50.820) AND IMPLANTED AN EXTENSION FOR REVERSE HUMERAL BODY (PN 1352.15.001) AND A REVERSE LINER +3MM (PN 1361.50.815). SURGERY WAS COMPLETED AS INTENDED. PATIENT IS MALE, DATE OF BIRTH (B)(6)1956. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Joint Laxity

  MAUDE report 24210807 ↗
• InjuryAug 6, 2024Unstable; Unstable

  SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2024 DUE TO INSTABILITY. THE PRIMARY SURGERY TOOK PLACE ON (B)(6) 2024, WHEN THE FOLLOWING COMPONENTS WERE IMPLANTED: SMR TT AUGMENTED 360 BASEPLATE (PART CODE 1375.15.507, LOT NUMBER 2311893, STERILIZATION (B)(4). SMR GLENOSPHERE ECCENTRICAL DIA. 40 MM (PART CODE 1376.09.041, LOT NUMBER 2226888, STERILIZATION (B)(4). SMR CONNECTOR + SCREW SMALL-R (PART CODE 1374.15.305, LOT NUMBER 2329787, STERILIZATION (B)(4). SMR GLENOID PEG TT SMALL-R (PART CODE 1375.14.652, LOT NUMBER 2313251, STERILIZATION (B)(4). SMR REVERSE LINER +6MM DIA. 40 MM (PART CODE 1365.50.820, LOT NUMBER 19AT2BA, STERILIZATION (B)(4). SMR HUMERAL BODY FINNED REVERSE (PART CODE 1352.15.050, LOT NUMBER 2403061, STERILIZATION (B)(4) SMR FINNED STEM (PART CODE 1304.15.180, LOT NUMBER 2303828, STERILIZATION (B)(4) FOUR CORTICAL BONE SCREWS. DURING THE REVISION SURGERY, THE GLENOSPHERE, THE CONNECTOR + SCREW, AND THE REVERSE LINER PREVIOUSLY IMPLANTED WERE REMOVED AND REPLACED BY THE FOLLOWING NEW COMPONENTS: SMR GLENOSPHERE DIA. 40 MM (PART CODE 1374.09.121, LOT NUMBER 2331854, STERILIZATION (B)(4). SMR CONNECTOR LAT. + 2MM + SCREW (PART CODE 1374.15.312, LOT NUMBER 2405388,

  Patient problems: Joint Laxity

  MAUDE report 19915913 ↗