AETOS Shoulder SystemRecalls & reported problems across all models
Smith & Nephew, Inc. · 44 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 177
- Deaths reported
- 0
- Injuries reported
- 37
- Recalls
- 0
We found 44 models of AETOS Shoulder System by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 177 adverse event reports in the FDA's MAUDE database, received between Aug 31, 2023 and Jul 14, 2026 — classified as 37 injuries, 140 malfunctions.
The most frequently reported specific device problem is “Fracture” (122 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported AETOS Shoulder System problems
Device problems
- Fracture122
- Device Dislodged or Dislocated18
- Adverse Event Without Identified Device or Use Problem16
- Break15
- Material Deformation13
- Material Twisted/Bent7
- Activation, Positioning or Separation Problem4
- Separation Failure4
Patient problems
- No Clinical Signs, Symptoms or Conditions140
- Joint Dislocation15
- Failure of Implant6
- Bone Fracture(s)4
- Fall4
- Medical device site infection4
- Joint Laxity3
- Pain3
AETOS Shoulder System models
44 models, most reported first. Each model has its own page with its reports, recalls and device details.
- AETOS Shoulder System INS-0990-861PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED40 reports
- 37 reports
- AETOS Shoulder System SCR-0990-822Orthopedic manual surgical instrument18 reports
- AETOS Shoulder System IMP-0990-835PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED7 reports
- 7 reports
- AETOS Shoulder System SCR-0990-862shoulder prosthesis, reverse configuration5 reports
- AETOS Shoulder System LNR-0990-200-380SPROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED4 reports
- AETOS Shoulder System LNR-0990-200-386SPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED3 reports
- AETOS Shoulder System LNR-0990-200-383SPROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED3 reports
- AETOS Shoulder System INS-0990-830-02shoulder prosthesis, reverse configuration3 reports
- AETOS Shoulder System GBP-0990-502-10FPROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED3 reports
- AETOS Shoulder System GBP-0990-502-15FPROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED3 reports
- AETOS Shoulder System GBP-0990-501-2PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED2 reports
- AETOS Shoulder System LNR-0990-200-423SPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED2 reports
- AETOS Shoulder System LNR-0990-200-426SPROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED2 reports
- AETOS Shoulder System INS-0990-830-01PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED2 reports
- 2 reports
- 2 reports
- 2 reports
- 2 reports
- AETOS Shoulder System SCW-0990-507-30shoulder prosthesis, reverse configuration2 reports
- AETOS Shoulder System STEM-0990-100-001PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED2 reports
- AETOS Shoulder System STEM-0990-100-002shoulder prosthesis, reverse configuration2 reports
- AETOS Shoulder System GLS0990-506-4200CPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED2 reports
- AETOS Shoulder System LNR-0990-200-429SPROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- AETOS Shoulder System LNR0990-200-420SRPROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- AETOS Shoulder System LNR0990-200-426SRPROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- AETOS Shoulder System LNR-0990-202-423LPROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED1 report
- AETOS Shoulder System LNR-0990-200-343Sshoulder prosthesis, reverse configuration1 report
- AETOS Shoulder System LNR-0990-200-346SPROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- AETOS Shoulder System INS-0990-830-00shoulder prosthesis, reverse configuration1 report
- AETOS Shoulder System INS-0990-830-03PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- AETOS Shoulder System RMB-0990-818-03BIT, DRILL1 report
- 1 report
- AETOS Shoulder System IMP-0990-836shoulder prosthesis, reverse configuration1 report
- 1 report
- AETOS Shoulder System SCW-0990-507-25shoulder prosthesis, reverse configuration1 report
- AETOS Shoulder System SCW-0990-507-40PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- AETOS Shoulder System SCW-0990-507-50PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- AETOS Shoulder System PST-0990-510-10PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED1 report
- AETOS Shoulder System GLS0990-506-3800CPROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- AETOS Shoulder System DRL-0990-849SBIT, DRILL1 report
- AETOS Shoulder System GLS0990-506-3401CPROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- AETOS Shoulder System GLS0990-506-4203CPROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED1 report
Recent AETOS Shoulder System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJul 14, 2026Separation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25818561 ↗MalfunctionJul 13, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25798325 ↗MalfunctionJun 30, 2026Break
IT WAS REPORTED THAT, DURING A TSA SURGERY, THE PEG OF ONE (1) HUMERAL HEAD TRL 47X16 CONCENTRIC BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25670049 ↗MalfunctionJun 12, 2026Break
IT WAS REPORTED THAT, DURING A TSA SURGERY, ONE (1) LINER TRIAL HEIGHT +0MM WAS BROKE DURING REDUCTION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25494358 ↗MalfunctionJun 3, 2026Fracture; Activation, Positioning or Separation Problem; Material Deformation
IT WAS REPORTED THAT, DURING A TSA SURGERY, THE CONNECTION OF FOUR (4) GLENOID REAMER DRIVER BROKE OFF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25381013 ↗MalfunctionJun 3, 2026Fracture; Activation, Positioning or Separation Problem; Material Deformation
IT WAS REPORTED THAT, DURING A TSA SURGERY, THE CONNECTION OF FOUR (4) GLENOID REAMER DRIVER BROKE OFF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25380958 ↗MalfunctionJun 3, 2026Fracture; Activation, Positioning or Separation Problem; Material Deformation
IT WAS REPORTED THAT, DURING A TSA SURGERY, THE CONNECTION OF FOUR (4) GLENOID REAMER DRIVER BROKE OFF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25380638 ↗MalfunctionJun 1, 2026Fracture
IT WAS REPORTED THAT, DURING A REVERSE TOTAL SHOULDER ARTHROPLASTY SURGERY, THE SCREW OF ONE (1) LINER TRIAL HEIGHT +0MM SPLIT IN HALF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25347435 ↗MalfunctionMay 31, 2026Fracture
IT WAS REPORTED THAT, DURING A REVERSE SURGERY, THE PLASTIC TIP OF ONE (1) HUMERAL HEAD GLENOSPHERE IMPACTOR BROKE IN HALF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25343550 ↗MalfunctionMay 31, 2026Fracture
IT WAS REPORTED THAT, DURING A AETOS SHOULDER SURGERY, THE SCREW PEG OF ONE (1) LINER TRIAL HEIGHT +0MM BROKE OFF AFTER TIGHTENING DOWN THE LINER HEIGHT TRIAL. NOTHING FELL INTO THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25342814 ↗MalfunctionMay 31, 2026Fracture
IT WAS REPORTED THAT, DURING AN RSA, THE TIP OF ONE (1) BASEPLATE/GLENOSPHERE INSERTER BROKE OFF INSIDE BASEPLATE UPON IMPACTION, NO PIECES LEFT IN PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25341874 ↗MalfunctionMay 28, 2026Fracture
IT WAS REPORTED THAT, DURING A TSA SURGERY, WHEN THE REAMING WAS STARTED THE TORX AT THE END OF ONE (1) GLENOID REAMER DRIVER SNAPPED OFF. THE BROKEN PIECE FELL ON THE FLOOR. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE (USING THE T HANDLE AND REAMING THE GLENOID BY HAND). NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25318566 ↗MalfunctionMay 1, 2026Fracture; Activation, Positioning or Separation Problem; Material Deformation
IT WAS REPORTED THAT, DURING A TSA SURGERY, THE CONNECTION OF FOUR (4) GLENOID REAMER DRIVER BROKE OFF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25058913 ↗MalfunctionApr 28, 2026Fracture
IT WAS REPORTED THAT, DURING A SHOULDER PROCEDURE, THE LINER TRIAL HEIGHT +0MM BROKE AT THE POST DURING SURGERY. THE ITEM DID NOT FRAGMENT, AND ALL PARTS WERE ACCOUNTED FOR. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK- UP. NO FURTHER COMPLICATIONS WERE REPORTED. CURRENT HEALTH OF PATIENT IS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25017120 ↗MalfunctionApr 24, 2026Positioning Failure; Nonstandard Device
IT WAS REPORTED THAT, DURING A RTSA SURGERY, WHEN IMPLANTING A GLENOID BASEPLATE 10 DEG FW AUG, THE CENTRAL, SUPERIOR, ANTERIOR AND POSTERIOR PERIPHERAL SCREWS LOCKED WELL, BUT THE INFERIOR SCREW DID NOT LOCK. THE SURGEON TRIED TO DRILL MULTIPLE TIMES AND ALSO TRIED MULTIPLE SCREWS, BUT STILL WOULD NOT LOCK. IT SEEMS LIKE THE BASEPLATE HAS FAULTY THREADS ON THE INFERIOR HOLE. SURGERY WAS RESUMED WITH THE SAME S+N PRODUCT, AND LEAVING THE INFERIOR BASEPLATE HOLE AND BONE HOLE OPEN, WITHOUT ANY SCREW. IT WAS COMPLETED WITH ONLY THREE PERIPHERICAL SCREWS AND ONE CENTRAL SCREW. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY, BUT NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: Perforation
MAUDE report 24988526 ↗
Other Smith & Nephew, Inc. products
- FAST-FIX18 models · 9,554 reports
- JOURNEY566 models · 6,250 reports · 4 recalls
- GENESIS II462 models · 4,599 reports · 2 recalls
- DYONICS, POWERMAX, ELITE2 models · 4,308 reports
- TRIGEN381 models · 3,599 reports · 5 recalls
- LEGION446 models · 2,039 reports · 4 recalls
- REAL INTELLIGENCE32 models · 2,017 reports · 3 recalls
- Coblation62 models · 2,126 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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