AETOS Shoulder System LNR-0990-200-426SRecalls & reported problems
Smith & Nephew, Inc. · 42MM REVERSE LINER PLS 6 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 00885556810620), received between May 2, 2024 and Nov 4, 2024 — 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
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 4, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT, AFTER A TSA REVISION SURGERY (CASE-(B)(4), THE PATIENT SUFFERED AGAIN OF A POLY DISSOCIATION. A SECOND REVISION SURGERY WAS PERFORMED IN ORDER TO EXPLANT THE 42MM REVERSE LINER +6 S, THE META HUMERAL STEM SIZE 2 S AND THE 42MM GLENOSPHERE CONCENTRIC. THIS IMPLANTS WERE REPLACED FOR TORNIER REVISION DEVICES. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Joint Dislocation
MAUDE report 20604558 ↗InjuryMay 2, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT AFTER A REVISION OF TOTAL SHOULDER ARTHROPLASTY SURGERY PERFORMED ON (B)(6) 2024, THE PATIENT EXPERIENCED POLY DISSOCIATION FOR THE SECOND TIME. THIS ADVERSE EVENT WAS ADDRESS BY A SECOND REVISION SURGERY ON (B)(6) 2024, DURING WHICH A 42MM REVERSE LINER +6 S AND A 42MM GLENOSPHERE CONCENTRIC WERE REPLACED WITH 38MM IMPLANTS AND A HUMERAL SPACER. THE PATIENT UNDERWENT A THIRD REVISION SURGERY ON (B)(6)2024.
Patient problems: Joint Dislocation
MAUDE report 19231936 ↗
Other PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED devices
- DJO SURGICAL 509-02-032Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED364 reports
- DELTA XTEND 130790036Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED171 reports
- DELTA XTEND 130770018Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED159 reports
- TRIGEN 71118200Smith & Nephew, Inc. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED123 reports
- DJO SURGICAL 509-02-432Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED119 reports
- DELTA XTEND 130738206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED116 reports
- COMPREHENSIVE SHOULDER SYSTEM 113633Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED2 recalls4 reports
- DELTA XTEND 130742206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED99 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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