SMR Shoulder 1360.50.820Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08033390080637), received between May 30, 2025 and Feb 17, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 18, 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.

• InjuryFeb 17, 2026Device Damaged by Another Device

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 DUE TO GLENOID COMPONENTS FAILURE. PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2023 WHEN THE ORIGINAL ASSEMBLY, CONSISTING OF SMR HUMERAL COMPONENTS COUPLED WITH ZIMMERBIOMET VRS CUSTOM GLENOID, WAS IMPLANTED. DURING REVISION THE SURGEON REMOVED THE FAILED GLENOID COMPONENTS, AND REPLACED THE SMR REVERSE HUMERAL BODY (PN 1352.15.010, LOT 2222575, STERILIZATION, (B)(4) AND SMR REVERSE LINER +6 MM (PN 1360.50.820, LOT 19AT06N, STERILIZATION (B)(4)) WITH ADAPTOR TAPER NEUTRAL (PN 1330.15.270), HUMERAL BODY TRAUMA LONG (PN 1350.15.020) AND CTA HEAD DIA54MM (PN 1323.09.540) TO CONVERT THE REVERSE PROSTHESIS TO AN ANATOMIC CONFIGURATION. SURGERY WAS COMPLETED AS INTENDED. PATIENT IS MALE, DATE OF BIRTH (B)(6) 1954. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Joint Laxity

  MAUDE report 24362075 ↗
• InjuryJul 18, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2025, DUE TO LOOSENING OF THE GLENOID COMPONENT. A COMPLAINT HAS BEEN FILED REGARDING THE SMR REVERSE LINER (HUMERAL COMPONENT), AS INFORMATION ABOUT THE SUSPECTED DEVICES RELATED TO THE GLENOID PART WAS NOT PROVIDED. THE SMR REVERSE LINER INVOLVED IN THIS EVENT IS THE FOLLOWING: SMR REVERSE LINER +6 MM (PART CODE 1360.50.820, LOT NUMBER 23AT0VA, STERILIZATION UNKNOWN) THE DATE OF THE INITIAL SURGERY IS UNKNOWN. THE PATIENT IS A FEMALE. THE EVENT HAPPENED IN THE UNITED STATES.

  Patient problems: Insufficient Information

  MAUDE report 22540944 ↗
• InjuryMay 30, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  REVISION SURGERY PERFORMED ON (B)(6) 2025, DUE TO LOOSENING. THE GLENOID IMPLANT AND BASEPLATE WERE PLACED TOO SUPERIOR IN THE GLENOID LEADING TO LOOSENING. AT THE TIME OF THE REVISION, THE FOLLOWING COMPONENTS WERE IMPLANTED ON THE GLENOID SIDE: SMR GLENOSPHERE Ø 36MM (PART CODE 1374.09.111, LOT NUMBER 2213083, STERILIZATION (B)(4), SMR REVERSE LINER +6 MM (PART CODE 1360.50.820, LOT NUMBER 20AT5KQ, STERILIZATION (B)(4), SMR SMALL-R CONNECTOR +4 (PART CODE 1374.15.314, LOT NUMBER 2212074, STERILIZATION (B)(4), SMR GLENOID PEG TT SMALL-R #L (PART CODE 1375.14.653, LOT NUMBER 2007768, STERILIZATION (B)(4), TT AUGM.360 BASEPLATE #S-R 7° (PART CODE 1375.15.507, LOT NUMBER 2213740, STERILIZATION (B)(4). DURING THE REVISION SURGERY, THE SMR REVERSE LINER PREVIOUSLY IMPLANTED WAS REPLACED BY THE FOLLOWING NEW COMPONENT: SMR RETENTIVE LINER STD (PART CODE 1361.50.810, LOT NUMBER 22AT144, STERILIZATION (B)(4). MOREOVER, IN REVISION THE SURGEON IMPLANTED A SMR REVERSE HUMERAL BODY 140° (PART CODE 1352.15.011), AND AN EXTENSION FOR HUMERAL REVERSE BODY (PART CODE 1352.15.001) AS WELL. PREVIOUS SURGERY WAS PERFORMED IN (B)(6) 2023. THE PATIENT IS A MALE, DATE OF BIRTH (B)(6) 1963. THE EVENT H

  Patient problems: Joint Laxity

  MAUDE report 22113297 ↗

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.