SMR Shoulder 1360.54.820Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08033390268219), received between Mar 19, 2026 and May 21, 2026 — classified as 2 injuries.

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

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 21, 2026Device Dislodged or Dislocated

  REVISION SURGERY OCCURRED ON (B)(6) 2026, DUE TO SHOULDER DISLOCATION. IN ORDER TO CREATE STABILITY, DURING THE REVISION PRE-EXISTING REVERSE LINER +6 MM D.36 MM (PN: 1360.54.820, LOT: 24AT62P, STER: 2500100) HAS BEEN EXPLANTED AND REPLACED WITH RETENTIVE REVERSE LINER +3MM DIA 36MM (PN: 1360.54.816), AND AN EXTENSION FOR HUMERAL REVERSE BODY +9MM (PN: 1352.15.001) HAS BEEN IMPLANTED. PREVIOUS SURGERY IS UNKNOWN. PATIENT IS FEMALE, DATE OF BIRTH ON (B)(6) 1959. EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Joint Dislocation

  MAUDE report 25239088 ↗
• InjuryMar 19, 2026Unstable

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2026 DUE TO SHOULDER INSTABILITY. THE PATIENT HAD A FRACTURE OF THE PROXIMAL HUMERUS THAT WAS INITIALLY TREATED WITH AN OPEN REDUCTION AND INTERNAL FIXATION (SURGICAL PROCEDURE TO REPAIR SEVERE BONE FRACTURES USING HARDWARES LIKE SCREWS, PLATES AND/OR RODS). AFTER A FAILURE OF THE ORIF, ON (B)(6) 2026 THE SURGEON OPTED TO PERFORM A REVERSE ARTHROPLASTY USING A COMBINATION OF ALTIVATE REVERSE GLENOID COMPONENTS (FROM OTHER MANUFACTURER) AND SMR SYSTEM ON THE HUMERAL SIDE, CONSISTING OF: - REVISION STEM CEMENTED DIA 13MM H 210 (PN 1309.15.138, LOT 1917114, STERILIZATION (B)(4)), - 140° FINNED REVERSE HUMERAL BODY (PN 1352.15.051, LOT 2519456, STERILIZATION (B)(4)), - REVERSE LINER 36MM +6MM (PN 1360.54.820, LOT 24AT117, STERILIZATION (B)(4)). DURING HEALING PROCESS PATIENT EXPERIENCED SOME SHOULDER INSTABILITY. DURING REVISION THE SURGEON REMOVED THE PRE-EXISTING LINER AND REPLACED IT WITH AN EXTENSION FOR HUMERAL REVERSE BODY (PN 1352.15.001) AND A RETENTIVE LINER REVERSE DIA36MM +6MM (PN 1360.54.821) TO INCREASE TISSUE TENSION. ALSO, THE GLENOSPHERE FROM OTHER MANUFACTURER WAS REPLACED WITH NEW ONE. SURGERY WAS COMPLETED AS INTENDED. THE PAT

  Patient problems: Joint Laxity

  MAUDE report 24638405 ↗