AETOS Shoulder System LNR-0990-200-383SRecalls & reported problems
Smith & Nephew, Inc. · 38MM REVERSE LINER PLS 3 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
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556810163), received between Oct 22, 2024 and Mar 28, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 Dislocated3
- Material Deformation1
- Material Twisted/Bent1
Patient problems
- Failure of Implant1
- Joint Dislocation1
- Joint Laxity1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMar 28, 2025Device Dislodged or Dislocated; Material Twisted/Bent; Device Dislodged or Dislocated; Material Twisted/Bent
IT WAS REPORTED THAT, AFTER A TSA SURGERY HAD BEEN PERFORMED ON (B)(6) 2024, THE PATIENT DISLOCATED REPEATEDLY, SO WARPING FOR THE INFERIOR LIP OF THE (1) 38MM REVERSE LINER +3 S WAS SUSPECTED. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH THE (1) 38MM REVERSE LINER +3 S WAS FOUND DISSOCIATED AND WAS SWAPPED OUT TO A RETENTIVE LINER. THE PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.
Patient problems: Joint Dislocation
MAUDE report 21721744 ↗InjuryNov 4, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT, AFTER A TSA SURGERY PERFORMED ON AN UNSPECIFIED DATE, THE 38MM REVERSE LINER +3 S CAME LOOSE FROM HUMERAL SPACER. A REVISION SURGERY WAS THEN PERFORMED ON (B)(6) 2024, IN ORDER TO REPLACE THE 38MM REVERSE LINER +3 S. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Failure of Implant
MAUDE report 20605834 ↗InjuryOct 22, 2024Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation
IT WAS REPORTED THAT, AFTER A TSA SURGERY HAD BEEN PERFORMED ON (B)(6) 2024 DUE TO A MASSIVE DELTOID AND CUFF TEAR ARTHROPATHY, THE PATIENT EXPERIENCED A SHOULDER DISLOCATION/POLY DISSOCIATION AROUND (B)(6) 2024. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2024, IN WHICH THE 38MM REVERSE LINER +3 S AND THE 38MM GLENOSPHERE CONCENTRIC WERE EXCHANGED FOR A 42MM GLENOSPHERE WITH THE CORRESPONDING POLY LINER. UPON EXTRACTION, IT WAS NOTED THAT THERE WAS A DEFORMITY ALONG THE OUTER LIP OF THE LINER. IT IS UNKNOWN IF THIS DEFORMITY CAUSED THE POLY TO DISSOCIATE, OR IF THE DEFORMITY WAS CAUSED BY THE EXTRACTION PROCESS. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.
Patient problems: Joint Laxity
MAUDE report 20509996 ↗
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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