AETOS Shoulder System LNR-0990-200-423SRecalls & reported problems
Smith & Nephew, Inc. · 42MM 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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556810613), received between Apr 28, 2024 and Dec 10, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 Dislocated2
Patient problems
- Joint Dislocation2
- Failure of Implant1
- Loss of Range of Motion1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 10, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT, AFTER A SECOND REVISION SURGERY HAD BEEN PERFORMED ON (B)(6) 2023, BECAUSE OF STIFFNESS AND WAKING UP WITH A DISLOCATED SHOULDER. A THIRD REVISION SURGERY WAS PERFORMED ON (B)(6) 2025, DUE TO POLY DISASSOCIATION. DURING WHICH, THE 42MM REVERSE LINER +3 S, 42MM GLENOSPHERE CONCENTRIC +3MM & META HUMERAL STEM SIZE 2 S WERE EXCHANGE. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.
Patient problems: Failure of Implant; Joint Dislocation
MAUDE report 23767125 ↗InjuryApr 28, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT, AFTER A FIRST REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 DUE TO IMPLANT DISLOCATION SUBSEQUENT TO A FALL, THE PATIENT PRESENTED STIFFNESS AND WOKE UP WITH A DISLOCATED SHOULDER ON (B)(6) 2023. IT WAS NOTICED THAT THE LINER WAS ADHERENT TO THE GLENOSPHERE, BUT DISSOCIATED FROM THE STEM. A SECOND REVISION SURGERY WAS PERFORMED ON (B)(6) 2024, DURING WHICH HE GLENOSPHERE WAS REPLACED WITH A 42MM GLENOSPHERE CONCENTRIC +3MM, WHILE THE LINER WAS REPLACED WITH A NEW ONE OF THE SAME PART NUMBER. THE HUMERAL SPACER +9 SMALL, THE 15 DEG AUGMENT BASEPLATE FULL WEDGE AND THE META HUMERAL STEM SIZE 2 S WERE RETAINED. PATIENT'S CURRENT HEALTH STATUS IS STABLE.
Patient problems: Joint Dislocation; Loss of Range of Motion
MAUDE report 19199311 ↗
Other PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED devices
- DJO SURGICAL 508-32-204Encore Medical, L.P. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall544 reports
- Comprehensive Reverse Shoulder 010000589Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall142 reports
- DELTA XTEND 130738203Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED175 reports
- DJO SURGICAL 509-00-432Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall117 reports
- Alliance® SBGL3007Zimmer, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED162 reports
- DELTA XTEND 130760138Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED146 reports
- DELTA XTEND 130790030Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED132 reports
- DJO SURGICAL 509-00-436Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented124 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.
How reports and recalls are matched · Editorial policy · Report an error on this page