Titan Reverse Shoulder SystemRecalls & reported problems across all models
Smith & Nephew, Inc. · 18 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 91
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls
- 0
We found 18 models of Titan Reverse Shoulder System by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 91 adverse event reports in the FDA's MAUDE database, received between Feb 14, 2023 and Jul 30, 2026 — classified as 10 injuries, 81 malfunctions.
The most frequently reported specific device problem is “Fracture” (60 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 Titan Reverse Shoulder System problems
Device problems
- Fracture60
- Break25
- Detachment of Device or Device Component3
- Device Dislodged or Dislocated3
- Adverse Event Without Identified Device or Use Problem2
- Degraded1
- Loosening of Implant Not Related to Bone-Ingrowth1
- Migration1
Patient problems
- No Clinical Signs, Symptoms or Conditions83
- Joint Dislocation5
- Failure of Implant2
- Inadequate Osseointegration1
- Insufficient Information1
Titan Reverse Shoulder System models
18 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Titan Reverse Shoulder System IMP-0961-064-SOrthopedic manual surgical instrument36 reports
- Titan Reverse Shoulder System INS-0960-094-01Orthopedic manual surgical instrument24 reports
- Titan Reverse Shoulder System INS-0961-048-01Orthopedic manual surgical instrument7 reports
- Titan Reverse Shoulder System GLS-0961-05C-Sshoulder prosthesis, reverse configuration4 reports
- Titan Reverse Shoulder System INS-0961-049-01Orthopedic manual surgical instrument3 reports
- Titan Reverse Shoulder System GLS-0961-05E-Sshoulder prosthesis, reverse configuration2 reports
- 2 reports
- 2 reports
- Titan Reverse Shoulder System SCR-0960-063-01Orthopedic manual surgical instrument2 reports
- Titan Reverse Shoulder System GBP-0961-094-Sshoulder prosthesis, reverse configuration1 report
- Titan Reverse Shoulder System BBS-0960-21SMLshoulder prosthesis, reverse configuration1 report
- 1 report
- Titan Reverse Shoulder System HDL-0960-065-01Orthopedic manual surgical instrument1 report
- 1 report
- Titan Reverse Shoulder System IMS-0960-070-01Orthopedic manual surgical instrument1 report
- Titan Reverse Shoulder System RDG-0961-078Orthopedic manual surgical instrument1 report
- Titan Reverse Shoulder System TRL-0961-05C-SOrthopedic manual surgical instrument1 report
- Titan Reverse Shoulder System TRL-0961-05E-SOrthopedic manual surgical instrument1 report
Recent Titan Reverse 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 30, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50090283 ↗MalfunctionJun 10, 2026Break
IT WAS REPORTED THAT, DURING A SHOULDER SURGERY, ONE (1) RSS GLENOID BASEPLATE IMPACTOR-S BROKE. 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 25465635 ↗MalfunctionMay 31, 2026Fracture
IT WAS REPORTED THAT, DURING A REVERSE TSA SURGERY, THE THREAD OF ONE (1) RSS HUMERAL BODY INSERTER/EXTRACTOR KNOB BROKE OFF WHILE IMPLANTING THE STEM. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25344330 ↗MalfunctionMay 5, 2026Break
IT WAS REPORTED THAT, DURING A REVERSE SHOULDER REPLACEMENT SURGERY, THE RSS GLENOID BASEPLATE IMPACTOR-S BROKE. THE PROCEDURE WAS PERFORMED, 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 25089507 ↗MalfunctionApr 30, 2026Fracture
IT WAS REPORTED THAT, DURING AETOS SHOULDER SURGERY, WHILE REMOVING THE TRIAL FROM THE PATIENT, THE THREADS OF THE RSS HUMERAL BODY INSERTER/EXTRACTOR KNOB BROKE OFF. 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 25045662 ↗MalfunctionFeb 4, 2026Fracture; Separation Failure
IT WAS REPORTED THAT, DURING A TITAN SHOULDER SURGERY, ONE (1) RSS HUMERAL BODY INSERTER/EXTRACTOR KNOB BROKE OFF INSIDE ONE (1) RSS HUMERAL BODY INSERTER / EXTRACTOR AND ONE (1) REAMER GUIDE BODY INSERTER/ EXTRACTOR MOD. THE BODY COULD NOT BE SEPARATED FROM THE INSERTER. NOTHING FELL INTO PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICES. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24259957 ↗MalfunctionFeb 3, 2026Fracture
IT WAS REPORTED THAT, DURING A SHOULDER SURGERY, ONE (1) RSS HUMERAL BODY INSERTER/EXTRACTOR KNOB BROKE. 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 24246084 ↗MalfunctionDec 8, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING A RTSA, THE THREADS OF ONE (1) RSS HUMERAL BODY INSERTER / EXTRACTOR BROKE WHEN DISASSEMBLING IT, AND THE RSS HUMERAL BODY INSERTER / EXTRACTOR STAYED ON THE IMPACTOR. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23742524 ↗MalfunctionDec 5, 2025Break; Fracture; Break; Fracture
IT WAS REPORTED THAT, DURING A TSA SURGERY, A RSS HUMERAL BODY INSERTER/EXTRACTOR KNOB BROKE. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED; HOWEVER, THERE WAS NO DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23730407 ↗MalfunctionDec 1, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING SURGERY, SURGEON BROKE THE RSS GLENOID BASEPLATE IMPACTOR-S. IT IS UNKNOWN HOW PROCEDURE WAS PERFORMED AND IF THERE WAS ANY DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23687011 ↗MalfunctionDec 1, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING SURGERY, SURGEON BROKE THE RSS GLENOID BASEPLATE IMPACTOR-S. IT IS UNKNOWN HOW PROCEDURE WAS PERFORMED AND IF THERE WAS ANY DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23686919 ↗MalfunctionNov 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT, DURING AN RTSA SURGERY ONE (1) STEM IMPACTION STAND MOD BROKE AS THE SCREW HOLDING IT TOGETHER WAS STRIPPED OUT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT SN BACK-UP. NO ADDITIONAL ANESTHETIC WAS REQUIRED. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23539188 ↗MalfunctionOct 30, 2025Break; Break
IT WAS REPORTED THAT, DURING REVERSE SHOULDER SURGERY, THE SURGEON BROKE ONE (1) RSS GLENOID BASEPLATE IMPACTOR-S. IT IS UNKNOWN HOW WAS THE PROCEDURE FINISHED, OR IF IT CAUSED ANY DELAY. NO INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23426656 ↗MalfunctionOct 9, 2025Break; Break
IT WAS REPORTED THAT, DURING A TSA SURGERY, TWO (2) RSS HUMERAL BODY INSERTER/EXTRACTOR KNOB BROKE. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED; HOWEVER, THERE WAS NO DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23262660 ↗MalfunctionSep 28, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A REVERSE SHOULDER ARTHROPLASTY, WHILE THE SURGEON WAS IMPLANTING THE GLENOID BASEPLATE WITH ONE (1) RSS GLENOID BASEPLATE IMPACTOR-S, THE TWO BLACK TIPS THAT SECURE THE IMPLANT BROKE OFF INTO THE IMPLANT WHEN THE SURGEON ATTEMPTED TO DISENGAGE THE IMPACTOR. THE SURGEON SUCCESSFULLY RETRIEVED THE BROKEN PIECES WITHOUT COMPLICATION; HOWEVER, THE IMPACTOR HAS BEEN RENDERED UNUSABLE. 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 23163855 ↗
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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