SMR Shoulder Liner (REF 1360.50.815)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08033390080620), received between Mar 27, 2025 and Oct 27, 2025 — 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. 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.

• InjuryOct 27, 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 STIFF SHOULDER. PREVIOUS SURGERY DATE UNKNOWN. THE FOLLOWING COMPONENT WAS REMOVED AND REPLACED BY A NEW ONE: - SMR REVERSE LINER + 3 MM (PART CODE 1360.50.815, LOT NUMBER 22AT1YH, STERILIZATION UNKNOWN). THE PATIENT IS A FEMALE, DATE OF BIRTH (B)(6) 1955. THE EVENT HAPPENED IN THE UNITED STATES.

  Patient problems: Implant Pain

  MAUDE report 23389241 ↗
• InjuryAug 29, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  REVISION SURGERY PERFORMED ON (B)(6) 2025, DUE TO GLENOID LOOSENING. IT WAS IMPLANTED A THIRD-PARTY GLENOID COMPONENT. THE FOLLOWING COMPONENT WAS REMOVED AND REPLACED WITH A NEW SMR RETENTIVE LINER: - SMR REVERSE LINER + 3 MM (PART CODE 1360.50.815, LOT NUMBER 22AT1YH, STERILIZATION (B)(4)). PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2024. THE PATIENT IS A FEMALE, DATE OF BIRTH (B)(6) 1952. THE EVENT HAPPENED IN THE UNITED STATES.

  Patient problems: Joint Laxity

  MAUDE report 22923288 ↗
• InjuryApr 30, 2025Unstable; Unstable

  SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2025 DUE TO INSTABILITY. THE PATIENT HAD A REVERSE SHOULDER ARTHROPLASTY WITH A 140° REVERSE BODY, +3MM LINER, AND A 36 GLENOSPHERE WITH A +2 ADAPTOR. THE PATIENT HAD STABILITY ISSUES AND WAS TAKEN BACK TO INCREASE LINER HEIGHT AND GLENOSPHERE LATERALIZATION TO +6MM LINER AND +4MM ADAPTER. THEREFORE, THE FOLLOWING COMPONENTS WERE REMOVED: SMR REVERSE LINER + 3 MM (PART CODE: 1360.50.815, LOT NUMBER: 23AT252, STERILIZATION 2400011). SMR GLENOSPHERE DIA. 36MM (PART CODE: 1374.09.111, LOT NUMBER: 2114595, STERILIZATION 2100307). SMR SMALL-R CONNECTOR +2 (PART CODE: 1374.15.312, LOT NUMBER: 2333194, STERILIZATION 2400017). THE ABOVE-MENTIONED DEVICES WERE REPLACED WITH THE FOLLOWING NEW ONES: SMR GLENOSPHERE DIA. 36MM (PART CODE: 1374.09.111, LOT NUMBER: 2402557, STERILIZATION 2400067). SMR SMALL-R CONNECTOR LAT. +4 (PART CODE: 1374.15.314, LOT NUMBER: 2412565, STERILIZATION 2400123). SMR REVERSE LINER +6 MM (PART CODE: 1360.50.820, LOT NUMBER: 23AT254, STERILIZATION 2300190). PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2024. THE PATIENT IS A FEMALE, DATE OF BIRTH ON (B)(6) 1955. THE EVENT HAPPENED IN THE UNITED STATES.

  Patient problems: Joint Laxity

  MAUDE report 21932842 ↗
• InjuryMar 27, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2025, DUE TO PATIENT SOFT TISSUE WAS LOOSE. IT WAS NECESSARY TO ADD MORE THICKNESS TO THE CONSTRUCTION, THE PRODUCT PERFORMED GREAT. PATIENT SOFT TISSUE WAS MAIN CONTRIBUTOR, AND A THICKER LINER WAS NECESSARY. DURING REVISION SURGERY, THE FOLLOWING REVERSE LINER PREVIOUSLY IMPLANTED WAS REMOVED: SMR REVERSE LINER + 3 MM (PART CODE 1360.50.815, LOT NUMBER 18AT1P1, STERILIZATION (B)(4)). THE REVERSE LINER (PART CODE 1360.50.810, LOT NUMBER 24AT1SE, STERILIZATION (B)(4)) AND EXTENSION FOR HUMERAL REVERSE BODY (PART CODE 1352.15.001, LOT NUMBER 2404517, STERILIZATION (B)(4)) WERE IMPLANTED. THE PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2020. DURING THIS SURGERY, THE FOLLOWING COMPONENTS WERE IMPLANTED TOGETHER WITH THE REVERSE LINER (WHICH WAS REMOVED DURING THE REVISION SURGERY): SMR GLENOID METAL BACK SMALL-R (PART CODE 1375.21.005, LOT NUMBER 1922107, STERILIZATION (B)(4)). SMR CONNECTOR + SCREW (PART CODE 1374.15.305, LOT NUMBER 1813958, STERILIZATION (B)(4)). SMR GLENOSPHERE DIA=36MM (PART CODE 1374.09.111, LOT NUMBER 1916170, STERILIZATION (B)(4)). SMR HUMERAL BODY (PART CODE 1352.15.010, LOT NUMBER 1921963, STERILIZATION (B)(4)). SMR

  Patient problems: Muscle/Tendon Damage

  MAUDE report 21709000 ↗

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.