SMR Shoulder Liner (REF 1365.50.815)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08033390102933), received between Apr 4, 2025 and Jul 2, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJul 2, 2026Device Dislodged or Dislocated

  REVISION SURGERY OCCURRED ON (B)(6) 2026, DUE TO SHOULDER DISLOCATION. PRE-EXISTING FOLLOWING COMPONENTS HAS BEEN EXPLANTED: SMR REVERSE LINER +3MM D.40MM (PART NUMBER 1365.50.815, LOT. 23AT24A, STER. 2400018); SMR GLENOSPHERE Ø 40MM (PART NUMBER 1374.09.121, LOT. 2415894, STER. 2400152); SMR CONNECTOR SMALL R (PART NUMBER 1374.15.305, LOT. 2325339, STER. 2300250); AND REPLACED WITH NEW FOLLOWING ONES: SMR REVERSE LINER RETENTIVE +3MM D.40MM (PART NUMBER 1365.50.816); SMR GLENOSPHERE Ø 40MM (PART NUMBER 1374.09.121); SMR CONNECTOR LAT. +4MM SMALL R (PART NUMBER 1374.15.314). PREVIOUS SURGERY HAS BEEN PERFORMED ON (B)(6) 2024. PATIENT IS MALE, DATE OF BIRTH (B)(6) 1943. EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Joint Dislocation

  MAUDE report 25687433 ↗
• InjuryJan 26, 2026Device Dislodged or Dislocated

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 DUE TO SHOULDER DISLOCATION. PREVIOUS SURGERY DATE IS UNKNOWN, AS WELL AS COMPLETE INFORMATION ON ORIGINAL PROSTHESIS. REVERSE LINER +3MM DIA40 (PART NUMBER 1365.50.815) HAS BEEN REMOVED, HOWEVER NO INDICATION OF WHICH MODEL OF LINER HAS BEEN IMPLANTED AS REPLACEMENT HAS BEEN PROVIDED. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Joint Dislocation

  MAUDE report 24176349 ↗
• InjuryJan 23, 2026Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 DUE TO SHOULDER DISLOCATION. PREVIOUS SURGERY IS UNKNOWN, AS WELL AS INFORMATION ABOUT ORIGINAL IMPLANT. DISLOCATION OCCURRED DUE TO SCAPULAR FRACTURE. SURGEON REMOVED THE REVERSE LINER (PART NUMBER 1365.50.815) AND REPLACED IT WITH A NEW RETENTIVE ONE (PART NUMBER 1365.50.816) AND THEN PROCEEDED WITH FIXING THE SCAPULA. SURGERY WAS COMPLETED AS INTENDED. PATIENT IS FEMALE, DATE OF BIRTH (B)(6) 1939. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Bone Fracture(s); Joint Dislocation

  MAUDE report 24159381 ↗
• InjuryDec 12, 2025Unstable; Unstable

  REVISION SURGERY PERFORMED ON (B)(6) 2025 DUE TO SHOULDER INSTABILITY. SURGEON REMOVED THE PRE-EXISTING SMR REVERSE LINER +3MM D.40MM (PART NUMBER: 1365.50.815, LOT: 23AT40L, STERILIZATION: 2400045) AND IMPLANTED AN EXTENSION FOR HUMERAL REVERSE BODY (PART NUMBER: 1352.15.001) AND A REVERSE LINER RETENTIVE STD DIA 40MM (PART NUMBER: 1365.50.811) TO IMPROVE SHOULDER STABILITY. PREVIOUS SURGERY DATE IS UNKNOWN, AS WELL AS OTHER COMPONENTS IMPLANTED IN PREVIOUS SURGERY. PATIENT IS A MALE, DATE OF BIRTH ON (B)(6) 1962. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Joint Laxity

  MAUDE report 23789513 ↗
• InjuryAug 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  SHOULDER REVISION SURGERY WAS PERFORMED ON (B)(6) 2025, DUE TO DISLOCATION. THE SURGEON IMPLANTED A THICKER LINER. THEREFORE, THE ONLY COMPONENT REMOVED AND REPLACED BY A NEW ONE IS THE FOLLOWING: SMR REVERSE LINER +3MM D.40MM (PART CODE 1365.50.815, LOT NUMBER 22AT0NB, STERILIZATION (B)(4). THE OTHER COMPONENTS PREVIOUSLY IMPLANTED WERE LEFT IN SITU: TT AUGM.360 BASEPLATE #S-R+2MM (PART CODE 1375.15.522, LOT NUMBER 2211656, STERILIZATION (B)(4). SMR REVERSE HUMERAL BODY SHORT (PART CODE 1352.15.005, LOT NUMBER 2202509, STERILIZATION (B)(4). SMR GLENOSPHERE Ø 40MM (PART CODE 1374.09.121, LOT NUMBER 2206405, STERILIZATION (B)(4), SMR CONNECTOR SMALL R (PART CODE 1374.15.305, LOT NUMBER 2213086, STERILIZATION (B)(4), SMR GLENOID PEG TT SMALL-R #M (PART CODE 1375.14.652, LOT NUMBER 2213319, STERILIZATION (B)(4). SMR CEMENTLESS FINNED STEM (PART CODE 1304.15.180, LOT NUMBER 2209462, STERILIZATION (B)(4). PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2022. THE PATIENT IS A FEMALE, DATE OF BIRTH (B)(6) 1951. THE EVENT HAPPENED IN THE UNITED STATES.

  Patient problems: Joint Dislocation

  MAUDE report 22872434 ↗
• InjuryJul 16, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  SHOULDER REVISION SURGERY WAS PERFORMED ON (B)(6) 2025, DUE TO DISLOCATION. THE FOLLOWING COMPONENTS PREVIOUSLY IMPLANTED WERE REMOVED AND REPLACED BY OTHER NEW COMPONENTS: SMR REVERSE LINER +3MM D.40MM (PART CODE: 1365.50.815, LOT NUMBER: 23AT40L, STERILIZATION: 2400045). CONNECTOR W. SCREW MED.LAT.7MM (PART CODE: 1974.15.302, LOT NUMBER: 2312609, STERILIZATION: 2300145). GLENOSPH.ECC. D.40MM ECC.4MM (PART CODE: 1976.09.040, LOT NUMBER: 2316007, STERILIZATION: 2300189). THE OTHER COMPONENTS PREVIOUSLY IMPLANTED WERE LEFT IN SITU: BASEPLATE D.25MM REGULAR (PART CODE: 1975.14.500, LOT NUMBER: 2405523, STERILIZATION: 2400083). SMR FINNED SHORT STEM D.21 (PART CODE: 1304.15.021, LOT NUMBER: 1917009, STERILIZATION: 2000019). SMR REVERSE HUMERAL BODY (PART CODE: 1352.15.010, LOT NUMBER: 2412894, STERILIZATION: 2400129). PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2024. THE PATIENT IS A MALE, DATE OF BIRTH ON (B)(6) 1957. THE EVENT HAPPENED IN THE UNITED STATES.

  Patient problems: Joint Dislocation

  MAUDE report 22517532 ↗
• InjuryJun 19, 2025Device Dislodged or Dislocated; Patient Device Interaction Problem; Device Dislodged or Dislocated; Patient Device Interaction Problem

  REVISION SURGERY PERFORMED ON (B)(6) 2025 DUE TO DISLOCATION. THE FOLLOWING COMPONENT PREVIOUSLY IMPLANTED, WAS REMOVED AND REPLACED BY A SMR REVERSE LINER RETENTIVE +6MM (PART CODE 1365.50.821): SMR REVERSE LINER +3MM D.40MM (PART CODE 1365.50.815, LOT NUMBER 24AT0US, STERILIZATION (B)(4). THE PATIENT UNDERWENT AN INITIAL TRAUMA SURGERY (PROXIMAL HUMERUS FRACTURE) ON (B)(6) 2025. THE OTHER DEVICES IMPLANTED ON THIS OCCASION WERE LEFT IN SITU DURING THE REVISION: SMR CEMENTLESS FINNED STEM (PART CODE 1304.15.170, LOT NUMBER 2427770, STERILIZATION (B)(4). SMR REVERSE FINNED HUMER. BODY (PART CODE 1352.15.050, LOT NUMBER 2310073, STERILIZATION (B)(4). SMR SMALL/STD CONNECTOR +2 (PART CODE 1374.15.322, LOT NUMBER 2427413, STERILIZATION (B)(4). SMR ECCENT. GLENOSPHERE DIA. 40MM (PART CODE 1376.09.041, LOT NUMBER 2433701, STERILIZATION (B)(4). AFTER THE REVISION SURGERY HEREBY REPORTED, THE PATIENT UNDERWENT ANOTHER REVISION PERFORMED ON (B)(6) 2025 (REPORTED BY COMPLAINT (B)(4), AND MFR. 3008021110-2025-00070). THE PATIENT IS A MALE, DATE OF BIRTH (B)(6) 1936. THE EVENT HAPPENED IN THE UNITED STATES.

  Patient problems: Joint Dislocation

  MAUDE report 22292117 ↗
• InjuryApr 4, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION SURGERY PERFORMED ON (B)(6) 2025, DUE TO IMPLANT DISLOCATION. PATIENT DISLOCATED TWICE. THE FOLLOWING LINER AND GLENOSPHERE WERE REMOVED AND THE SURGEON PUT IN A LATERALIZED GLENOSPHERE AND A LARGER RETENTIVE POLY: SMR REVERSE LINER +3MM D.40MM (PART CODE 1365.50.815, LOT NUMBER 23AT24A, STERILIZATION (B)(4), SMR ECCENT. GLENOSPHERE Ø 40MM (PART CODE 1376.09.041, LOT NUMBER 2307061, STERILIZATION (B)(4). PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2025. THE PATIENT IS A MALE, DATE OF BIRTH (B)(6) 1955. THE EVENT HAPPENED IN THE UNITED STATES.

  Patient problems: Joint Dislocation

  MAUDE report 21770689 ↗