SMR Shoulder Liner (REF 1365.50.810)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08033390102919), received between Jan 23, 2026 and May 18, 2026 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 18, 2026Device Dislodged or Dislocated

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2026 DUE TO SHOULDER DISLOCATION. PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2026 FOR A REVERSE TOTAL SHOULDER ARTHROPLASTY WITH FOLLOWING COMPONENTS: MONOBLOCK REVERSE TT BASEPLATE DIA25MM REGULAR (PN 1975.14.500) PRIMA TT GLENOSPHERE DIA40MM (PN 1974.09.040) PRIMA GLENOSPHERE CONNECTOR HIGH LATERALIZATION 9MM (PN 1974.15.304) SMR FINNED STEM SHORT DIA 18MM (PN 1304.15.018) 140° HUMERAL REVERSE BODY (PN 1352.15.011) REVERSE LINER STD DIA40MM (PN 1365.50.810, LOT 24AT5NW, STERILIZATION (B)(4). AFTER DISLOCATION, THE SURGEON REVISED THE PATIENT AND REPLACED THE PRE-EXISTING LINER WITH ANOTHER ONE OF SAME TYPE. SURGERY WAS COMPLETED AS INTENDED. PATIENT IS MALE, DATE OF BIRTH (B)(6) 1954. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Joint Dislocation

  MAUDE report 25200758 ↗
• InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2026 DUE TO CUFF FAILURE. PREVIOUS SURGERY IS UNKNOWN, AS WELL AS COMPLETE PRODUCT INFORMATION OF ORIGINAL IMPLANT. THE PATIENT HAD A PRE-EXISTING REVERSE CONFIGURATION OF SMR SHOULDER PROSTHESIS CONSISTING OF A TT METAL BACK BASEPLATE 360 + 4MM (PN 1375.15.524) WITH AN 40MM GLENOSPHERE (PN 1374.09.121). AFTER SUFFERING FROM ACROMION TO ACROMION FRACTURE, DUE TO OVER LATERALIZATION ACCORDING TO THE SURGEON WHO REVISED THE IMPLANT, THE PATIENT BECAME LAX. DURING THE REVISION PROCEDURE, THE SURGEON CHOSE TO INCREASE THE POLY LINER THICKNESS FROM A STANDARD SIZE TO A +6MM: SMR REVERSE LINER STANDARD 40MM (PN 1365.50.810) WAS REMOVED AND REPLACED WITH THICKER ONE. THIS CHANGE GUARANTEED THE APPROPRIATE TENSIONING TO THE ROTATOR CUFF. THE SURGEON DECIDED TO NOT REPLACE OTHER COMPONENTS SUCH AS THE HUMERAL REVERSE BODY BECAUSE OF THE RISK OF A TUBEROSITY FRACTURE. SURGERY WAS COMPLETED AS INTENDED. THE PATIENT IS MALE, DATE OF BIRTH (B)(6) 1959. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 24813212 ↗
• InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2026, DUE TO PATIENT COMPLAINT OF PAIN. ORIGINAL SURGERY OCCURRED ON (B)(6) 2025, AND FOLLOWING COMPONENTS WERE IMPLANTED: - SMR GLENOID PEG TT SMALL-R #M (PN 1375.14.652, LOT. 2424760, STER. (B)(4)); - SMR CONNECTOR SMALL R (PN 1374.15.305, LOT. 2126602, STER. (B)(4)); - TT AUGM.360 BASEPLATE #S-R 15° (PN 1375.15.515, LOT. 2100640, STER. (B)(4)); - SMR GLENOSPHERE Ø 40MM (PN 1374.09.121, LOT. 2427991, STER. (B)(4)); - SMR REVERSE LINER STD D.40MM (PN 1365.50.810, LOT. 23AT40K, STER. (B)(4)); - SMR REVERSE FINNED HUMERAL BODY (PN 1352.15.050, LOT. 2023455, STER. (B)(4)); - SMR CEM. REVISION STEM Ø15 MM (PN 1309.15.158, LOT. 1520565, STER. (B)(4)). DURING REVISION SURGERY, HEREBY REPORTED, THE PRE-EXISTING HUMERAL BODY, REVERSE LINER, CONNECTOR AND GLENOSPHERE WERE REMOVED AND REPLACED WITH: - SMR 140° HUMERAL BODY FINNED REVERSE (PN 1352.15.051); - EXTENSION FOR HUMERAL REVERSE BODY (PN 1352.15.001); - SMR REVERSE LINER RETENTIVE STD DIA. 40 MM (PN1365.50.811); - SMR CONNECTOR LAT +2MM + SCREW (PN 1374.15.312); - GLENOSPHERE DIA 40 MM (PN 1374.09.121). SURGERY HAS BEEN COMPLETED AS INTENDED. PATIENT IS MALE, DATE OF BIRTH (B)(6) 1951. EVENT

  Patient problems: Implant Pain

  MAUDE report 24813211 ↗
• InjuryMar 19, 2026Device Dislodged or Dislocated

  REVISION SURGERY OCCURRED ON (B)(6) 2026 DUE TO IMPLANT DISLOCATION. PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2025 AND FOLLOWING COMPONENTS WERE IMPLANTED: - FINNED STEM DIA 14 MM L. 80 MM (PN 1304.15.140, LOT. 2501562, STER. (B)(4)). - HUMERAL BODY REVERSE (PN 1352.15.010, LOT. 2524608, STER. (B)(4)). - REVERSE LINER STD 40MM (PN 1365.50.810, LOT. 24AT31Q, STER. (B)(4)). - ECCENTRICAL GLENOSPHERE 40MM (PN 1376.09.041, LOT. 2517012, STER. (B)(4)). - CONNECTOR WITH SCREW SMALL R (PN 1374.15.305, LOT. 2525209, STER. (B)(4)). - METAL BACK GLENOID SMALL-R (PN 1375.21.005, LOT. 2523946, STER. (B)(4)). - BONE SCREW DIA 6,5 MM L20 MM (PN 8420.15.010, LOT. 2523113, STER. (B)(4)). PATIENT DISLOCATED AND, AS A CONSEQUENCE, DURING REVISION THE SURGEON REMOVED ABOVE MENTIONED REVERSE LINER STD 40MM AND REPLACE IT WITH A REVERSE RETENTIVE STANDARD 40MM (PN 1365.50.811). SURGERY WAS COMPLETED AS INTENDED. PATIENT IS FEMALE, DATE OF BIRTH (B)(6) 1950. EVENT OCCURRED IN UNITED STATES.

  Patient problems: Joint Dislocation

  MAUDE report 24638408 ↗
• InjuryJan 23, 2026Device Dislodged or Dislocated

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 DUE TO SHOULDER DISLOCATION. REPORTEDLY, PATIENT WAS REACHING FOR A DRAWER IN THE KITCHEN AT WAIST LEVEL, WHEN GRABBING AND PULLING THE DRAWER OUT, HER LEFT SHOULDER DISLOCATED. PREVIOUS SURGERY DATE IS UNKNOWN, AS WELL AS PRODUCT INFORMATION OF PRE-EXISTING IMPLANT. DURING REVISION, THE SURGEON REMOVED THE PRE-EXISTING LINER (PART NUMBER 1365.50.810) AND REPLACED IT WITH A NEW ONE AND ADDED AN EXTENSION FOR HUMERAL REVERSE BODY (PART NUMBER 1352.15.001) TO IMPROVE STABILITY. SURGERY WAS COMPLETED AS INTENDED. PATIENT IS FEMALE, DATE OF BIRTH (B)(6) 1954. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Joint Dislocation

  MAUDE report 24159382 ↗