SMR Shoulder Liner (REF 1360.50.810)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08033390080613), received between Jul 18, 2024 and Jan 27, 2026 — classified as 4 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. 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.

• InjuryJan 27, 2026Patient Device Interaction Problem

  SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2025, DUE TO GLENOID LOOSENING. THE PATIENT IS A FEMALE, DATE OF BIRTH (B)(6) 1956. THE EVENT HAPPENED IN THE UNITED STATES.

  Patient problems: Insufficient Information

  MAUDE report 24188853 ↗
• InjuryJun 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY PERFORMED ON (B)(6) 2025, DUE TO INFECTION. THERE WAS AN INFECTION FROM THE SKIN INCISION, THE SURGEON WANTED TO DO A POLY SWAP. THE FOLLOWING LINER WAS THE ONLY COMPONENT REMOVED AND REPLACED BY A SIMILAR DEVICE: SMR REVERSE LINER STANDARD (PART CODE: 1360.50.810, LOT NUMBER: 22AT1GH, STERILIZATION 2200243). THE OTHER COMPONENTS WERE LEFT IN SITU: SMR METAL-BACK GLENOID SMALL R (PART CODE: 1375.21.005, LOT NUMBER: 2433154, STERILIZATION 2500010) . SMR SMALL-R CONNECTOR +2 (PART CODE: 1374.15.312, LOT NUMBER: 2500708, STERILIZATION 2500041). SMR GLENOSPHERE DIA. 36MM (PART CODE: 1374.09.111, LOT NUMBER: 2436656, STERILIZATION 2500015). FINNED REVERSE HUM. BODY 140° (PART CODE: 1352.15.051, LOT NUMBER: 2416428, STERILIZATION 2400165). SMR CEMENTLESS FINNED STEM (PART CODE: 1304.15.140, LOT NUMBER: 2312939, STERILIZATION 2300232). PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2025. THE PATIENT IS A FEMALE, DATE OF BIRTH ON (B)(6) 1969. THE EVENT HAPPENED IN THE UNITED STATES.

  Patient problems: Medical device site infection

  MAUDE report 22288364 ↗
• InjuryFeb 12, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  REVISION SURGERY DUE TO SEPTIC LOOSENING PERFORMED ON (B)(6) 2025. PATIENT COMPLAINED OF PAIN AND X-RAYS WERE TAKEN. IT WAS DETERMINED THAT THE STEM APPEARED LOOSE A DUE TO A POSSIBLE INFECTION. A 1ST STAGE INFECTION SURGERY WAS SCHEDULED. THE FOLLOWING COMPONENTS WERE REMOVED: - SMR CEMENTLESS FINNED STEM (PART NUMBER 1304.15.180, LOT NUMBER 1808774, STERILIZATION (B)(4)) - SMR REVERSE HUMERAL BODY (PART NUMBER 1352.15.010, LOT NUMBER 1809657, STERILIZATION (B)(4)) - SMR REVERSE LINER STANDARD (PART NUMBER 1360.50.810, LOT NUMBER 18AT0GK, STERILIZATION (B)(4)) - SMR GLENOSPHERE Ø36 MM (PART NUMBER 1376.09.030, LOT NUMBER 1809534, STERILIZATION (B)(4)). THE LIMA LONG REVISION STEM WAS TRIALED ALONG WITH MULTIPLE EXTENSIONS AND LINERS. IT WAS DETERMINED THAT THIS COMBINATION WOULD NOT REDUCE PROPERLY. A TORNIER REVISION STEM WAS TRIALED ALONG WITH VARIOUS TRAYS AND LINERS. IT WAS DETERMINED THAT THIS WAS A GOOD FIT AND THE DEFINITIVE IMPLANTS WERE IMPLANTED ALONG WITH A LIMA 36 ECCENTRIC GLENOSPHERE. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2018. THE PATIENT IS A FEMALE, DATE OF BIRTH (B)(6) 1964. THE EVENT HAPPENED IN THE UNITED STATES.

  Patient problems: Medical device site infection

  MAUDE report 21362127 ↗
• InjuryJul 18, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2024, DUE TO DISLOCATION. DURING THE REVISION SURGERY, THE FOLLOWING COMPONENTS WERE REMOVED: SMR REVERSE LINER STANDARD (PART CODE 1360.50.810, LOT NUMBER 23AT0V8, STERILIZATION NUMBER (B)(4). SMR GLENOSPHERE Ø 36MM (PART CODE 1374.09.111, LOT NUMBER 2325319, STERILIZATION NUMBER (B)(4). SMR CONNECTOR SMALL R (PART CODE 1374.15.305, LOT NUMBER 2327395, STERILIZATION NUMBER (B)(4). THE COMPONENTS ABOVE MENTIONED WERE REPLACED BY THE FOLLOWING NEW COMPONENTS: SMR REVERSE LINER RETENTIVE (PART CODE 1361.50.815, LOT NUMBER 21AT0F5, STERILIZATION NUMBER (B)(4). SMR GLENOSPHERE Ø 36MM (PART CODE 1374.09.111, LOT NUMBER 2218959, STERILIZATION NUMBER (B)(4). SMR CONNECTOR+SCREW SMALL R (PART CODE 1374.15.305, LOT NUMBER 2411586, STERILIZATION NUMBER (B)(4). THE PREVIOUS SURGERY TOOK PLACE ON (B)(6)2024. DURING THIS SURGERY, THE SMR REVERSE HUMERAL BODY SHORT (PART CODE 1352.15.005, LOT NUMBER 2202133, STERILIZATION NUMBER (B)(4). WAS ALSO IMPLANTED (AND NOT REMOVED DURING THE REVISION SURGERY). THE PATIENT IS A FEMALE, DATE OF BIRTH (B)(6)1956. THE EVENT HAPPENED IN THE UNITED STATES.

  Patient problems: Joint Dislocation

  MAUDE report 19772700 ↗

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.