SMR System 1360.50.810Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08033390273589), received between Jun 18, 2025 and May 4, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Unstable” (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.

• InjuryMay 4, 2026Device Dislodged or Dislocated

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2026 DUE TO DISLOCATION. PATIENT CLINICAL HISTORY SUMMARY IS THE FOLLOWING: (B)(6) 2025: ORIGINAL SURGERY WITH (B)(6) COMPONENTS (FINNED STEM DIA. 19 MM L. 80MM PN 1304.15.190; 140° HUMERAL BODY REVERSE PN 1352.15.011; EXTENSION FOR HUMERAL REVERSE BODY PN 1352.15.001; SMR REVERSE LINER +3MM PN 1360.50.815) AND DJO ALTIVATE GLENOID COMPONENTS. (B)(6) 2026: REVISION SURGERY FOR HUMERAL STEM LOOSENING (PREVIOUSLY REPORTED WITH REFERENCE MFR. 3008021110-2026-00183) WAS PERFORMED TO REPLACE ALL EXISTING COMPONENTS WITH NEW ONES (ON THE HUMERAL SIDE THE ABOVE MENTIONED COMPONENTS WERE REPLACED WITH FINNED STEM DIA. 20 MM L. 80MM PN 1304.15.200; 140° HUMERAL BODY REVERSE PN 1352.15.011; AND SMR REVERSE LINER +6MM PN 1360.50.820). (B)(6) 2026: REVISION SURGERY FOR SHOULDER DISLOCATION (REPORTED WITH REFERENCE MFR. 3008021110-2026-00195) WAS PERFORMED REPLACING THE ABOVE MENTIONED 140° HUMERAL BODY REVERSE AND SMR REVERSE LINER +6MM WITH NEW EXTENSION FOR HUMERAL REVERSE BODY (PN 1352.15.001, LOT 2539123, STERILIZATION 2600021), 140° HUMERAL BODY FINNED REVERSE (PN 1352.15.051, LOT 2541489, STERILIZATION 2600021) AND SMR REVERSE LINER STANDARD (PN 1

  Patient problems: Joint Dislocation

  MAUDE report 25067091 ↗
• InjuryApr 8, 2026Unstable

  REVISION SURGERY HAS BEEN PERFORMED ON (B)(6) 2026 DUE TO SHOULDER PROSTHESIS INSTABILITY. PREVIOUS SURGERY OCCURRED ON (B)(6) 2025. DURING THE REVISION, PRE-EXISTING SMR REVERSE LINER STANDARD (PN 1360.50.810, LOT. 24AT5P6) HAS BEEN REMOVED AND REPLACED WITH SMR RETENTIVE LINER +6MM (PN 1361.50.820). ALSO, THE ORIGINALLY IMPLANTED GLENOSPHERE, FROM ANOTHER MANUFACTURER, HAS BEEN REMOVED AND REPLACED WITH A NEW ONE. SURGERY HAS BEEN COMPLETED AS INTENDED. PATIENT IS FEMALE, DATE OF BIRTH (B)(6) 1949. EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Joint Laxity

  MAUDE report 24813220 ↗
• InjuryJan 28, 2026Break; Degraded; Unstable; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 ON A REVERSE SHOULDER PROSTHESIS. PREVIOUS SURGERY IS UNKNOWN, AS WELL AS COMPLETE PRODUCT INFORMATION OF ORIGINAL ASSEMBLY. REPORTEDLY, THE REVERSE SHOULDER PROSTHESIS HAS BEEN IMPLANTED FOR SEVERAL YEARS BEFORE FAILING. ACCORDING TO INFORMATION PROVIDED, THE GLENOSPHERE ROTATED, LEADING THE POLY LINER TO WEAR AND EVENTUALLY BREAKING, WHICH CAUSED PAIN AND INSTABILITY FOR THE PATIENT. DURING REVISION THE SURGEON REMOVED THE PRE-EXISTING SMR METAL-BACK GLENOID STD (PART NUMBER 1375.21.010), SMR GLENOSPHERE Ø36 MM (PART NUMBER 1374.09.110) AND THE BROKEN SMR REVERSE LINER STANDARD (PART NUMBER 1360.50.810) AND IMPLANTED A NEW LINER REVERSE LINER +3MM (PART NUMBER 1365.50.815). NO INFORMATION REGARDING GLENOID COMPONENTS IMPLANTED IN REVISION HAS BEEN PROVIDED. HOWEVER, SURGERY HAS BEEN COMPLETED AS INTENDED. PATIENT IS FEMALE, DATE OF BIRTH (B)(6) 1957. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Implant Pain

  MAUDE report 24201332 ↗
• InjuryJun 18, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2025, DUE TO SUSPECTED INFECTION. THE PATIENT DEVELOPED A SUSPECTED WOUND INFECTION. DURING THE REVISION SURGERY HEREBY REPORTED THE SURGEON DECIDED TO WASH OUT THE WOUND AND SWAP POLY LINER TO AVOID POTENTIAL INFECTION. THE FOLLOWING COMPONENT WAS REMOVED: SMR REVERSE LINER STANDARD (PART CODE 1360.50.810, LOT NUMBER 24AT31M, STERILIZATION (B)(4). THIS COMPONENT WAS REPLACED BY THE FOLLOWING NEW ONE: SMR RETENTIVE LINER (PART CODE 1361.50.810, LOT NUMBER 20AT149, STERILIZATION (B)(4). THE OTHER COMPONENTS PREVIOUSLY IMPLANTED WERE LEFT IN SITU: SMR GLENOID PEG TT SMALL-R #S (PART CODE 1375.14.651, LOT NUMBER 2435269, STERILIZATION (B)(4). SMR GLENOID BASEPLATE SMALL-R (PART CODE 1375.15.605, LOT NUMBER 2500055, STERILIZATION (B)(4). SMR GLENOSPHERE Ø 36MM (PART CODE 1374.09.111, LOT NUMBER 2504424, STERILIZATION (B)(4). PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2025. THE PATIENT WAS A FEMALE, DATE OF BIRTH (B)(6) 1943. THE EVENT HAPPENED IN THE UNITED STATES.

  Patient problems: Wound Infection

  MAUDE report 22287590 ↗

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.