SMR System 1376.09.031Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08033390272339), received between Jan 3, 2024 and Jul 1, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K163397); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 1, 2026Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY HAS BEEN PERFORMED ON (B)(6) 2026 DUE TO INFECTION. PREVIOUS SURGERY IS UNKNOWN, AS WELL AS COMPLETE PRODUCT INFORMATION OF ORIGINAL ASSEMBLY. DURING REVISION, THE PRE-EXISTING SMR REVERSE HUMERAL BODY (PN 1352.15.010), REVERSE LINER +3MM (PN 1360.50.815), ECCENTRICAL GLENOSPHERE DIA36MM (PN 1376.09.031) AND CONNECTOR (PN 1374.15.310) HAS BEEN REMOVED AND REPLACED WITH NEW ONES. AN ADDITIONAL BONE SCREW (PN 8420.15.010) HAS BEEN ADDED TO THE BASEPLATE FOR BETTER FIXATION. SURGERY HAS BEEN COMPLETED AS INTENDED. PATIENT IS FEMALE, DATE OF BIRTH J(B)(6) 1964. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Medical device site infection

  MAUDE report 25680183 ↗
• InjuryJul 9, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  SHOULDER REVISION SURGERY WAS PERFORMED ON (B)(6) 2025, DUE TO DISLOCATION. THE PATIENT WAS DISLOCATING AND THE SURGEON DECIDED TO IMPLANT A LATERALIZED GLENOSPHERE AND A +3 RETENTIVE POLY. THE FOLLOWING COMPONENTS WERE REMOVED: - SMR REVER. LINER RETENTIVE STD (PART CODE 1361.50.810, LOT NUMBER 20AT18S, STERILIZATION UNKNOWN). - SMR CONNECTOR SMALL R (PART CODE 1374.15.305, LOT NUMBER 2432915, STERILIZATION (B)(4)). - SMR ECCENT. GLENOSPHERE Ø 36MM (PART CODE 1376.09.031, LOT NUMBER 2433704, STERILIZATION (B)(4)). PREVIOUS SURGERY PERFORMED ON (B)(6) 2025. THE PATIENT IS A MALE, DATE OF BIRTH (B)(6) 1952. THE EVENT HAPPENED IN THE UNITED STATES.

  Patient problems: Joint Dislocation

  MAUDE report 22458718 ↗
• InjuryJul 1, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2023, FOR AN SMR REVERSE IMPLANT DUE TO DISLOCATION. THE PREVIOUS SURGERY HAD TAKEN PLACE ON (B)(6) 2022. AFTER SEVERAL X-RAYS CONFIRMED DISLOCATION, RADIOLUCENCY, AND IMPLANT TURNED, A PROMADE CASE WAS OPENED AND IN THE FIRST STAGE, THE FOLLOWING EXPLANTS WERE REMOVED: SMR ECCENT. GLENOSPHERE Ø 36MM (CODE 1376.09.031, LOT N. 2111077, STER. N. (B)(4), SMR REVERSE LINER + 6 MM (CODE 1360.50.020, LOT N. 19AT0TK, STER. N. (B)(4), SMR REVERSE HUMERAL BODY SHORT (CODE 1352.15.005, LOT N. 2107182, STER. N. (B)(4), SMR CONNECTOR SMALL R (CODE 1374.15.305, LOT N. 19AT0TK, STER. N. (B)(4), SMR GLENOID PEG TT SMALL-R #XL (CODE 1375.14.654, LOT N. 1907801, STER. N. (B)(4), SMR GLENOID BASEPLATE SMALL-R (CODE 1375.15.650, LOT N. 2111129, STER. N. (B)(4), BONE SCREW Ø6,5 H.25MM (CODE 8420.15.020, LOT N. 2124330, STER. N. (B)(4), BONE SCREW Ø6,5 H.30MM (CODE 8420.15.030, LOT N. 2023138, STER. N. (B)(4), BONE SCREW Ø6,5 H.40MM (CODE 8420.15.050, LOT N. 2016867, STER. N. (B)(4), BONE SCREW Ø6,5 H.40MM (CODE 8420.15.050, LOT N. 2016867, STER. N. (B)(4). PATIENT: FEMALE, DOB: (B)(6) 1964. THE SAME PATIENT UNDERWENT ANOTHER REVISION SURGERY PERFORMED ON (B)(6)

  Patient problems: Joint Dislocation

  MAUDE report 22370032 ↗
• InjuryJan 3, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2021 DUE TO RIGHT REVERSE SHOULDER DISLOCATION. PATIENT: FEMALE, 75 YEARS OLD. DURING THE REVISION SURGERY, THE FOLLOWING DEVICES WERE REMOVED: SMR ECCENT. GLENOSPHERE Ø 36MM (PRODUCT CODE: 1376.09.031 LOT NR. 2017864 - STER. NR. 2000317); SMR REVERSE LINER + 6 MM (PRODUCT CODE: 1360.50.020 LOT. NR. 17AT0U9 - STER. NR. 1700198) - NOT SOLD IN US; SMR CEMENTED STEM Ø12 MM (PRODUCT CODE: 1306.15.120 LOT. NR. 1813538); SMR REVERSE HUMERAL BODY SHORT (PRODUCT CODE: 1352.15.005 LOT. NR: 2021424 - STER. NR. 2000404); SMR CONNECTOR SMALL STD (PRODUCT CODE: 1374.15.310 LOT. NR. 2111864 - STER. NR. 2100184) . EVENT OCCURRED IN UNITED KINGDOM. PREVIOUS SURGERY PERFORMED ON (B)(6) 2021.

  Patient problems: Implant Pain; Joint Dislocation

  MAUDE report 18435258 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K163397. One submission often covers many models, so check the product and lot details in each record.

• Z-1317-2023 · Feb 21, 2023 · Open, Classified
  SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210