SMR System 1360.50.820Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08033390273619), received between Feb 25, 2026 and May 18, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K110598); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 18, 2026Detachment of Device or Device Component; Device Dislodged or Dislocated

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2026 DUE TO SHOULDER DISLOCATION. PREVIOUS SURGERY OCCURRED ON (B)(6) 2025 WHEN ORIGINAL ANATOMIC PROSTHESIS WAS CONVERSED TO A REVERSE CONFIGURATION DUE TO ROTATOR CUFF FAILURE (PREVIOUSLY REPORTED WITH MFR. 3008021110-2026-00073). PATIENT DISLOCATED AND THE SURGEON DECIDED TO PERFORM A REVISION SURGERY SINCE THEY COULD NOT REDUCE THE DISLOCATION OF THE REVERSE IN OTHER WAY. DURING REVISION, THE PRE-EXISTING SMR SMALL/STD CONNECTOR +2MM (PN 1374.15.322, LOT 2514593, STERILIZATION (B)(4), GLENOSPHERE Ø 36MM (PN 1374.09.111,LOT 2515422, STERILIZATION 2500135) AND SMR REVERSE LINER + 6 MM (PN 1360.50.820, LOT 23AT40J, STERILIZATION 2400057) WERE REMOVED AND REPLACED WITH NEW CONNECTOR, ECCENTRICAL GLENOSPHERE DIA40MM (PN 1376.09.041) AND REVERSE LINER RETENTIVE +3MM (PN 1365.50.816). REVERSE LINER WAS FOUND DISSOCIATED FROM HUMERAL BODY DURING REVISION. SURGERY WAS COMPLETED AS INTENDED. PATIENT IS MALE, DATE OF BIRTH (B)(6) 1951. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Joint Dislocation

  MAUDE report 25200759 ↗
• InjuryMay 4, 2026Device Dislodged or Dislocated

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2026 DUE TO DISLOCATION. PATIENT CLINICAL HISTORY SUMMARY IS THE FOLLOWING: (B)(6) 2025: ORIGINAL SURGERY WITH SMR HUMERAL COMPONENTS (FINNED STEM DIA. 19 MM L. 80MM PN 1304.15.190; 140° HUMERAL BODY REVERSE PN 1352.15.011; EXTENSION FOR HUMERAL REVERSE BODY PN 1352.15.001; SMR REVERSE LINER +3MM PN 1360.50.815) AND DJO ALTIVATE GLENOID COMPONENTS. (B)(6) 2026: REVISION SURGERY FOR HUMERAL STEM LOOSENING (PREVIOUSLY REPORTED WITH REFERENCE MFR. 3008021110-2026-00183) WAS PERFORMED TO REPLACE ALL EXISTING COMPONENTS WITH NEW ONES (ON THE HUMERAL SIDE THE ABOVE MENTIONED COMPONENTS WERE REPLACED WITH FINNED STEM DIA. 20 MM L. 80MM PN 1304.15.200; 140° HUMERAL BODY REVERSE PN 1352.15.011, LOT 2535453, STERILIZATION (B)(6); AND SMR REVERSE LINER +6MM PN 1360.50.820, LOT 25AT1AB, STERILIZATION (B)(6)). (B)(6) 2026: REVISION SURGERY FOR SHOULDER DISLOCATION (HEREBY REPORTED) WAS PERFORMED REPLACING THE ABOVE MENTIONED 140° HUMERAL BODY REVERSE AND SMR REVERSE LINER +6MM WITH NEW EXTENSION FOR HUMERAL REVERSE BODY (PN 1352.15.001), 140° HUMERAL BODY FINNED REVERSE (PN 1352.15.051) AND SMR REVERSE LINER STANDARD (PN 1360.50.810). (B)(6) 2026: REVISI

  Patient problems: Joint Dislocation

  MAUDE report 25067089 ↗
• InjuryFeb 25, 2026Detachment of Device or Device Component

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2026 DUE TO DISASSEMBLY OF COMPONENTS. PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2025 AND FOLLOWING COMPONENTS WERE IMPLANTED: SMR REVERSE LINER + 6 MM (PART NUMBER: 1360.50.820, LOT. 24AT5P8, STERILIZATION N. 2500009). SMR CONNECTOR SMALL STD (PART NUMBER: 1374.15.310, LOT: 2500907, STERILIZATION N. 2500027). SMR GLENOSPHERE Ø 36MM (PART NUMBER: 1374.09.111, LOT: 2506966, STERILIZATION N. 2500066). SMR METAL-BACK GLENOID SMALL (PART NUMBER: 1375.21.020, LOT: 2435106, STERILIZATION N. 2500053). SMR CEMENTLESS FINNED STEM (PART NUMBER: 1304.15.210, LOT: 2102161, STERILIZATION N. 2100078). SOME MONTHS AFTER ORIGINAL SURGERY THE ABOVE-MENTIONED REVERSE POLY LINER WAS FOUND LOOSE. DURING REVISION SURGERY LINER WAS EXPLANTED AND REPLACED WITH A NEW ONE FROM SAME LOT. SURGERY WAS COMPLETED AS INTENDED. PATIENT IS A MALE, DATE OF BIRTH ON (B)(6) 1940. THE EVENT OCCURRED IN UNITES STATES.

  Patient problems: Loose body in joint

  MAUDE report 24442723 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K110598. One submission often covers many models, so check the product and lot details in each record.

• Z-1711-2016 · Apr 8, 2016 · Terminated
  SMR glenosphere impactor/extractor; Used to implant the glenosphere in the SMR Reverse Shoulder replacement.