SMR Shoulder Liner (REF 1365.50.816)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08033390102957), received between Aug 2, 2025 and Dec 12, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Degraded” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 12, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION SURGERY PERFORMED ON (B)(6) 2025 DUE TO DISLOCATION. DURING PREVIOUS SURGERY, PERFORMED ON (B)(6) 2025, FOLLOWING COMPONENTS WERE IMPLANTED: SMR METAL-BACK GLENOID SMALL R (PART NUMBER 1375.21.005, LOT 2507198, STERILIZATION (B)(6)), SMR CONNECTOR SMALL R (PART NUMBER 1374.15.305, LOT 2514287, STERILIZATION (B)(6)), SMR ECCENT. GLENOSPHERE Ø 40MM (PART NUMBER 1376.09.041, LOT 2522183, STERILIZATION (B)(6)), SMR CEMENTLESS FINNED STEM (PART NUMBER 1304.15.160, LOT 2432439, STERILIZATION (B)(6)), SMR REVERSE FINNED HUMER. BODY (PART NUMBER 1352.15.050, LOT 2521987, STERILIZATION (B)(6)), SMR REVERSE LINER RETENTIVE (PART NUMBER 1365.50.816, LOT 24AT5WB, STERILIZATION (B)(6)). PATIENT DISLOCATED AND NEEDED A THICKER INSERT. AS TROUBLESHOOTING SURGEON REPLACED THE PRE-EXISTING LINER WITH A REVERSE LINER RETENTIVE +3MM DIA 40MM (PART NUMBER 1365.50.816) AND ADDED AN EXTENSION FOR HUMERAL REVERSE BODY (PART NUMBER 1352.15.001). PATIENT IS A MALE, DATE OF BIRTH (B)(6) 1953. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Joint Dislocation

  MAUDE report 23789435 ↗
• InjuryAug 2, 2025Degraded; Degraded

  SHOULDER REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 DUE TO OSTEOLYSIS AND WEAR OF THE SMR REVERSE LINER RETENTIVE (PRODUCT CODE:1365.50.816, LOT: 14L0397 - STER.(B)(4)). THE PATIENT UNDERWENT SURGERY IN 2018 FOR A REVERSE SHOULDER REPLACEMENT USING SMR SYSTEM. ORIGINALLY, A 150-REVERSE BODY, +3MM RETENTIVE LINER, AND A 40MM GLENOSPHERE WERE IMPLANTED. PATIENT PRESENTED IN CLINIC WITH SOME PAIN AND THE SURGEON IDENTIFIED POSSIBLE OSTEOLYSIS ON HUMERUS. NOTCHING OR VOLUMETRIC WEAR COULD HAVE CAUSED THIS, BUT IT WAS UNDETERMINED. UPON REVISION SURGERY, IT WAS NOTED THAT THE POLY HAD SLIGHT DAMAGE ALONG THE EDGES AND SOME OSTEOLYSIS WAS PRESENT. THE REVERSE BODY WAS SWAPPED WITH A 140-DEGREE SHORT BODY AND +6MM LINER. THE GLENOSPHERE WAS CHANGED TO A 36MM GLENOSPHERE WITH A +4MM LATERALIZED ADAPTER. THE ORIGINAL METAL BACKED BASEPLATE WAS RETAINED. THE SURGEON WAS PLEASED WITH THE REDUCTION INCLUDING NECK ANGLE CHANGE AND FURTHER LATERALIZATION AND BELIEVES THIS WILL CORRECT THE PROBLEMS THAT LEAD TO REVISION. PREVIOUS REVISION SURGERY TOOK PLACE ON (B)(6) 2018. THE DEVICE EXPLANTED: · SMR REVERSE LINER RETENTIVE (PRODUCT CODE:1365.50.816, LOT:14L0397 - STER.(B)(4)). · SMR REVERSE H

  Patient problems: Osteolysis

  MAUDE report 22693988 ↗