SMR Shoulder Liner (REF 1365.50.821)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08033390102971), received between Aug 6, 2024 and Jun 16, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 reports).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJun 16, 2026Device Dislodged or Dislocated

  REVISION SURGERY OCCURRED ON (B)(6) 2026, DUE TO MULTIPLE SHOULDER DISLOCATION OVERTIME. COMPLETE PATIENT CLINICAL HISTORY IS FOLLOWING REPORTED: ON (B)(6) 2026, PATIENT UNDERWENT REVERSE TOTAL SHOULDER ARTHROPLASTY WITH SMR HUMERAL COMPONENTS CONSISTING OF: REVISION STEM DIA16MM H 150MM (PN 1308.15.164); SMR 140° HUMERAL BODY REVERSE (PN 1352.15.011); EXTENSION FOR HUMERAL REVERSE BODY (PN 1352.15.001); RETENTIVE LINER +6MM 36MM (PN 1361.50.820). DJO GLENOSPHERE. DURING FIRST REVISION SURGERY, PERFORMED ON (B)(6) 2026, DUE TO DISLOCATION (ALREADY REPORTED WITH MFR 3008021110-2026-00184), ALL ABOVE MENTIONED COMPONENTS WERE REMOVED AND REPLACED WITH SIMILAR ITEMS, WITH EXCEPTION OF A 140° FINNED HUMERAL BODY REVERSE (PN 1352.15.051) AND A RETENTIVE LINER +6MM DIA 40MM (PN 1365.50.821) FOR SIZE COMPATIBILITY WITH THE DJO 40MM/+4MM LATERALIZED GLENOSPHERE THAT HAS BEEN IMPLANTED. AT THE TIME OF THE SECOND REVISION, HEREBY REPORTED AND OCCURRED ON (B)(6) 2026, PATIENT'S IMPLANT WAS CONSISTING OF: REVISION STEM DIA16MM H 150MM (PN 1308.15.164, LOT. 2004055. STER. (B)(4); EXTENSION FOR HUMERAL REVERSE BODY (PN 1352.15.001, LOT. 2519453, STER. (B)(4); 140° FINNED HUMERAL BODY REVERSE (PN

  Patient problems: Joint Dislocation

  MAUDE report 25516464 ↗
• InjuryApr 8, 2026Degraded

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2026, DUE TO WEAR OF SMR REVERSE LINER RETENTIVE. PREVIOUS SURGERY IS UNKNOWN AS WELL AS COMPLETE INFORMATION OF ORIGINAL IMPLANT. DURING THE REVISION THE PRE-EXIISTING SMR COMPONENTS WERE REMOVED AN REPLACED WITH: SMR FINNED STEM (PN1304.15.190); SMR HUMERAL BODY REVERSE (PN 1352.15.010); EXTENSION FOR HUMERAL REVERSE BODY (PN 1352.15.001); SMR REVERSE LINER RETENTIVE (PN 1365.50.821); SMR CONNECTOR + SCREW (PN 1374.15.310); SMR GLENOSPHERE ECCENTRICAL (PN 1376.09.041). SURGERY HAS BEEN COMPLETED AS INTENDED. PATIENT IS MALE, DATE OF BIRTH (B)(6) 1965. EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Insufficient Information

  MAUDE report 24813214 ↗
• 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. DURING REVISION THE SURGEON REMOVED THE PRE-EXISTING SMR REVERSE COMPONENTS: TT AUGM.360 BASEPLATE #S-R 7° (PART NUMBER 1375.15.507). SMR GLENOID PEG TT SMALL-R #M (PART NUMBER 1375.14.652) SMR GLENOSPHERE Ø 40MM (PART NUMBER 1374.09.121) SMR REVERSE LINER RETENTIVE (PART NUMBER 1365.50.821). THE ASSEMBLY HAS THEN BEEN CONVERTED TO AN ANATOMIC CONFIGURATION IMPLANTING AN EXTENSION FOR HUMERAL REVERSE BODY (PART NUMBER 1352.15.001), AN ADAPTOR 36MM FOR REVERSE BODY (PART NUMBER 1352.15.200) AND A CTA HEAD DIA 54MM (PART NUMBER 1323.09.540). SURGERY HAS BEEN COMPLETED AS INTENDED. THE PATIENT IS MALE, DATE OF BIRTH (B)(6) 1950. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Joint Dislocation

  MAUDE report 24201306 ↗
• InjuryJan 9, 2026Device Dislodged or Dislocated

  Revision surgery was performed on (b)(6) 2025 due to shoulder dislocation.Previous surgery was performed on (b)(6) 2025: SMR REVERSE LINER RETENTIVE +6mm Dia40mm (part number 1365.50.821, lot 21AT0FB, sterilization 2100270) was implanted along with glenoid components (baseplate and glenosphere) from other manufacturer.Since patient dislocated, revision surgery was scheduled to add the SMR Extension for Humeral Reverse body (part number 1352.15.001) and replace the liner with a new one (part number 1365.50.821). Reduction was performed and stability was confirmed with this new assembly. Surgery has been completed as intended.Patient is a female, date of birth (b)(6).The event occurred in the United States.

  Patient problems: Joint Dislocation

  MAUDE report 24018184 ↗
• InjuryDec 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  REVISION SURGERY PERFORMED ON (B)(6) 2025 DUE TO DISASSEMBLY OF COMPONENTS. EXTENSION AND LINER CAME APART FROM HUMERAL BODY. COMPLAINED COMPONENT SMR REVERSE LINER RETENTIVE (PART NUMBER: 1365.50.821, LOT: 24AT6AX, STERILIZATION: 2500062) WAS REPLACED WITH A NEW SMR REVERSE LINER RETENTIVE +6MM DIA 40MM (PART NUMBER: 1365.50.821), AND REVERSE HUMERAL BODY (PART NUMBER: 1352.15.010) AND ITS EXTENSION (PART NUMBER: 1352.15.001) WERE IMPLANTED AS TROUBLESHOOTING. PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2025. THE PATIENT IS A MALE, DATE OF BIRTH ON (B)(6) 1962. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Joint Laxity

  MAUDE report 23789503 ↗
• InjuryDec 2, 2025Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2025, DUE TO DISLOCATION/LUXATION AND INSTABILITY. ORIGINAL SURGERY WAS A REVERSE SHOULDER ARTHROPLASTY PERFORMED ON JULY 16TH 2025 FOR A TRAUMA FRACTURE. DURING ORIGINAL SURGERY FOLLOWING COMPONENTS WERE IMPLANTED: - SMR GLENOID BASEPLATE STANDARD (PART NUMBER 1375.15.610, LOT NUMBER 2418193, STERILIZATION (B)(4)), - SMR GLENOID PEG TT S/STD #M (PART NUMBER 1375.14.662, LOT NUMBER 1908192, STERILIZATION (B)(4)), - SMR SMALL/STD CONNECTOR +4 (PART NUMBER 1374.15.324, LOT NUMBER 2505999, STERILIZATION (B)(4)), - SMR ECCENT. GLENOSPHERE Ø 40MM (PART NUMBER 1376.09.041, LOT NUMBER 2509088, STERILIZATION (B)(4)), - SMR REVERSE HUMERAL BODY (PART NUMBER 1352.15.010, LOT NUMBER 2506300, STERILIZATION (B)(4)), - SMR CEMENTLESS FINNED STEM (PART NUMBER 1304.15.230, LOT NUMBER 2306953, STERILIZATION (B)(4), - SMR REVERSE LINER RETENTIVE (PART NUMBER 1365.50.821, LOT NUMBER 20AT04A, STERILIZATION (B)(4)). SUBSEQUENTLY, PATIENT WAS SUBLUXING AND HAD SOME SHOULDER INSTABILITY. SMR REVERSE RETENTIVE LINER ABOVE MENTIONED WAS REMOVED AND EXTENSION FOR HUMERAL REVERSE BODY (PART NUMBER 1352.15.001) AND SMR REVERSE LINER +3MM DIA 40MM (PART NUMBER 1365

  Patient problems: Joint Dislocation

  MAUDE report 23693164 ↗
• InjuryAug 6, 2024Unstable; Unstable

  SECOND SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2024, DUE TO INSTABILITY. THE PREVIOUS REVISION SURGERY WAS PERFORMED ON (B)(6) 2024, AND THIS EVEN WAS REGISTERED AS INTERNAL COMPLAINT (B)(4) AND REPORTED TO THE FDA WITH MFR 3008021110-2024-00065. DURING THE SECOND REVISION SURGERY, THE FOLLOWING COMPONENTS, IMPLANTED ON (B)(6) 2024, WERE REMOVED: - SMR RETENTIVE LINER + 6 MM (PART CODE 1365.50.821, LOT NUMBER 23AT08E, STERILIZATION (B)(4)). - SMR EXTENSION FOR REVERSE HUMERAL BODY (PART CODE 1352.15.001, LOT NUMBER 2208535, STERILIZATION (B)(4)). THEY WERE REPLACED BY THE FOLLOWING COMPONENTS: - SMR RETENTIVE LINER + 6 MM DIA. 40 MM (PART CODE 1365.50.821, LOT 23AT3BW, STERILIZATION (B)(4)). - SMR EXTENSION FOR REVERSE HUMERAL (PART CODE 1352.15.001, LOT 2411657, STERILIZATION (B)(4)). THE PRIMARY SURGERY TOOK PLACE ON (B)(6) 2024. THE PATIENT IS A MALE, DATE OF BIRTH (B)(6) 1950. EVENT HAPPENED IN THE UNITED STATES.

  Patient problems: Joint Laxity

  MAUDE report 19915915 ↗