AETOS Shoulder System LNR-0990-200-380SRecalls & reported problems
Smith & Nephew, Inc. · 38MM REVERSE LINER PLS 0 SML · Class 2 · Implant
All models of AETOS Shoulder System (44)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556810170), received between Mar 26, 2024 and Feb 25, 2026 — classified as 4 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated4
- Material Deformation1
Patient problems
- Joint Dislocation3
- Failure of Implant1
- Joint Laxity1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryFeb 25, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT, AFTER RTSA SURGERY HAD BEEN PERFORMED ON (B)(6) 2025, THE PATIENT EXPERIENCED A JOINT DISLOCATION DUE TO A DISASSOCIATION OF THE META HUMERAL STEM SIZE 1 S WITH THE 38MM REVERSE LINER +0 S. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2026, IN WHICH THE META HUMERAL STEM SIZE 1 S AND THE 38MM REVERSE LINER +0 S WERE REMOVED AND REPLACED WITH NEW COMPONENTS. CURRENT PATIENT'S HEALTH STATUS IS UNKNOWN.
Patient problems: Joint Dislocation
MAUDE report 24441672 ↗InjuryOct 29, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT, AFTER A TSA SURGERY HAD BEEN PERFORMED ON (B)(6) 2024, THE PATIENT EXPERIENCED A SHOULDER DISLOCATION AROUND ON (B)(6) 2024. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2024, IN WHICH THE 38MM REVERSE LINER +0 S AND THE 38MM GLENOSPHERE CONCENTRIC WERE EXCHANGED FOR A 42MM GLENOSPHERE WITH THE CORRESPONDING POLY LINER. UPON EXTRACTION NO DISSOCIATION OR IMPLANT MALFUNCTION WAS NOTED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.
Patient problems: Joint Laxity
MAUDE report 20556670 ↗InjuryApr 1, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT, AFTER A TOTAL SHOULDER ARTHROPLASTY SURGERY WAS PERFORMED ON (B)(6) 2023, THE PATIENT EXPERIENCED POLY DISSOCIATION FOR THE THIRD TIME. THIS ADVERSE EVENT WAS ADDRESSED BY A REVISION SURGERY ON (B)(6) 2024, DURING WHICH ALL HUMERAL COMPONENTS WERE REMOVED AND REPLACED WITH TORNIER FLEX COMPONENTS (COMPETITOR'S DEVICES). UPON INSPECTION OF THE DEVICES, IT WAS NOTICED THAT A 38MM REVERSE LINER +0 S HAD SEVERAL WRAPS AND DEFECTS ALONG THE OUTER EDGES. THE PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.
Patient problems: Joint Dislocation
MAUDE report 19012319 ↗InjuryMar 26, 2024Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation
IT WAS REPORTED THAT, AFTER A SHOULDER SURGERY HAD BEEN PERFORMED ON (B)(6) 2023, PATIENT EXPERIENCED DISLOCATION. DURING PROCEDURE, IT WAS OBSERVED THAT THE REVERSE LINER WAS ABLE TO ROCK SLIGHTLY IN THE STEM AND THAT IT WAS SEVERELY DEFORMED FROM THE DISLOCATION. THIS ADVERSE EVENT WAS ADDRESSED BY REVISION SURGERY ON (B)(6) 2024, TO EXCHANGE THE 38MM REVERSE LINER +0 S. PATIENT'S CURRENT HEALTH IS UNKNOWN.
Patient problems: Failure of Implant; Joint Dislocation
MAUDE report 18977082 ↗
Other PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED devices
- Equinoxe 320-42-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-38-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-42-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls87 reports
- Equinoxe 320-38-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls43 reports
- Equinoxe 320-42-13Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls41 reports
- Equinoxe 320-10-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented132 reports
- Equinoxe 320-36-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls27 reports
- Equinoxe 320-42-10Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls14 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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