SMR System 1360.50.815Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08033390273602), received between May 30, 2025 and Apr 8, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 8, 2026Unstable

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2026 DUE TO SHOULDER INSTABILITY. PREVIOUS SURGERY IS UNKNOWN, AS WELL AS COMPLETE PRODUCT INFORMATION OF ORIGINAL IMPLANT. DURING REVISION THE PRE-EXISTING SMR REVERSE LINER (PN (B)(4)), HUMERAL EXTENSION +9MM (PN 1352.15.001), CONNECTOR SMALL (PN 1374.15.305) AND GLENOSPHERE DIA36MM (PN 1374.09.111) WERE REMOVED AND REPLACED WITH NEW CONNECTOR, GLENOSPHERE ECCENTRICAL DIA40MM (PN 1376.09.041), HUMERAL EXTENSION AND REVERSE LINER RETENTIVE +6MM DIA40MM (PN 1365.50.821), TO INCREASE THE ASSEMBLY THICKNESS. SURGERY WAS COMPLETED AS INTENDED. PATIENT IS MALE, DATE OF BIRTH (B)(6) 1957. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Joint Laxity

  MAUDE report 24813221 ↗
• InjuryJan 29, 2026Device Dislodged or Dislocated

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 DUE TO SHOULDER DISLOCATION. REPORTEDLY, PATIENT HAS CONTINUOUS SHOULDER DISLOCATION. PREVIOUS SURGERY IS UNKNOWN, AS WELL AS COMPLETE PRODUCT INFORMATION OF ORIGINAL IMPLANT. DURING REVISION THE SURGEON REMOVED THE PRE-EXISTING SMR REVERSE LINER + 3 MM (PN 1360.50.815). NO INFORMATION HAS BEEN PROVIDED ABOUT SIZE AND TYPE OF REPLACEMENT LINER. HOWEVER, SURGERY HAS BEEN COMPLETED AS INTENDED. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Joint Dislocation

  MAUDE report 24210771 ↗
• InjuryJan 28, 2026Device Dislodged or Dislocated

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 DUE TO SHOULDER DISLOCATION. PREVIOUS SURGERY IS UNKNOWN, AS WELL AS COMPLETE PRODUCT INFORMATION OF ORIGINAL IMPLANT. REPORTEDLY, PATIENT DISLOCATED THE SHOULDER WHILE LIFTING A LADDER. SURGEON REMOVED THE PRE-EXISTING REVERSE LINER +3MM (PART NUMBER 1360.50.815) AND REVISED THE ASSEMBLY WITH AN EXTENSION FOR HUMERAL REVERSE BODY (PART NUMBER 1352.15.001) AND A THICKER REVERSE LINER RETENTIVE +6 DIA40MM (PART NUMBER 1365.50.821). SURGERY HAS BEEN 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 24201305 ↗
• InjuryMay 30, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2025, DUE TO INFECTION. THE FOLLOWING GLENOSPHERE, CONNECTOR AND REVERSE LINER WERE REMOVED AND REPLACED BY NEW COMPONENTS: SMR REVERSE LINER + 3 MM (PART CODE 1360.50.815, LOT NUMBER 24AT5P7, STERILIZATION (B)(4)). SMR CONNECTOR SMALL R (PART CODE 1374.15.305, LOT NUMBER 2432923, STERILIZATION (B)(4)). SMR ECCENT. GLENOSPHERE Ø 36MM (PART CODE 1376.09.031, LOT NUMBER 2434937, STERILIZATION (B)(4)). THE OTHER COMPONENTS PREVIOUSLY IMPLANTED WERE LEFT IN SITU: SMR CEMENTLESS MINI STEM (PART CODE 1304.15.120, LOT NUMBER 2223142, STERILIZATION (B)(4)). SMR REVERSE HUMERAL BODY SHORT (PART CODE 1352.15.005, LOT NUMBER 2435343, STERILIZATION (B)(4)). SMR METAL-BACK GLENOID SMALL R (PART CODE 1375.21.005, LOT NUMBER 2426024, STERILIZATION (B)(4)). PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2025. THE PATIENT IS A FEMALE, 52 YEARS OLD. THE EVENT HAPPENED IN THE UNITED STATES.

  Patient problems: Medical device site infection

  MAUDE report 22115063 ↗

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.