Titan Modular Shoulder System 2.5Recalls & reported problems across all models
Smith & Nephew, Inc. · 13 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 37
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 0
We found 13 models of Titan Modular Shoulder System 2.5 by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 37 adverse event reports in the FDA's MAUDE database, received between Apr 26, 2022 and Jun 1, 2026 — classified as 2 injuries, 35 malfunctions.
The most frequently reported specific device problem is “Fracture” (26 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 Modular Shoulder System 2.5 problems
Device problems
- Fracture26
- Break10
- Adverse Event Without Identified Device or Use Problem1
- Detachment of Device or Device Component1
- Device Dislodged or Dislocated1
Patient problems
- No Clinical Signs, Symptoms or Conditions35
- Failure of Implant1
- Muscle/Tendon Damage1
Titan Modular Shoulder System 2.5 models
13 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Titan Modular Shoulder System 2.5 ROD-0923-040-001Orthopedic manual surgical instrument8 reports
- Titan Modular Shoulder System 2.5 MAL-0920-085-01Orthopedic manual surgical instrument6 reports
- 5 reports
- 4 reports
- 4 reports
- 2 reports
- 2 reports
- Titan Modular Shoulder System 2.5 GLN-0926-030-02APROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- 1 report
- Titan Modular Shoulder System 2.5 MHH-0923-010-4617CPROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED1 report
- 1 report
- 1 report
- 1 report
Recent Titan Modular Shoulder System 2.5 adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 1, 2026Fracture
IT WAS REPORTED THAT, DURING A RTSA SURGERY, THE THREADS OF ONE (1) TSS HEAD CUTTING TEMPLATE ROD. 2.5 BROKE OFF INTO THE INSERTER DURING IMPACTING. 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 25354361 ↗MalfunctionApr 22, 2026Fracture
IT WAS REPORTED THAT, DURING A RTSA, WHEN TRYING TO MALLET BROACH HANDLE OUT, ONE (1) TSS HEAD CUTTING TEMPLATE ROD. 2.5 WAS STRUCK AND THREADS 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 24953458 ↗MalfunctionFeb 26, 2026Break
IT WAS REPORTED THAT DURING A REVERSE TOTAL SHOULDER, THE PLASTIC PART ON SLOTTED MALLET BROKE WHILE USING. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24462652 ↗MalfunctionFeb 24, 2026Fracture
IT WAS REPORTED THAT, DURING A REVERSE TSA SURGERY, THE TIP OF ONE (1) 2.8 MM GLENOID DRILL SHAFT WAS BROKEN AND WOULD NOT ALLOW ATTACHMENTS TO STAY ON. 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 24430042 ↗MalfunctionFeb 10, 2026Fracture
IT WAS REPORTED THAT DURING A REVERSE TOTAL SHOULDER, THE PLASTIC PIECE OF THE SLOTTED MALLET BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24303461 ↗MalfunctionDec 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT, DURING A REVERSE TOTAL SHOULDER, USING THE PERIPHERAL BASEPLATE REAMER, THE DOCTOR NOTICED SOMETHING OFF WITH THE DRIVER WHILE SPINNING, PULLED IT OUT OF THE JOINT AND THE SPRING AND COLLAR INSIDE THE 2.8MM GLENOID DRILL SHAFT FELL OUT ON THE FLOOR. THE ATTACHMENT WAS STILL IN THE T-HANDLE AND CAUGHT THE OUTER BLACK SHAFT. NOTHING FELL INSIDE THE PATIENT; IT WAS CONFIRMED WITH X-RAYS. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE, BY USING A RONJOUR. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23900408 ↗MalfunctionDec 11, 2025Break; Break
IT WAS REPORTED THAT, DURING A TSA SURGERY, ONE (1) COMBO INSERTER/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 23779579 ↗MalfunctionDec 10, 2025Break; Break
IT WAS REPORTED THAT, DURING A TSA SURGERY, ONE (1) FIN-LOCK SIZER. 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 23773763 ↗MalfunctionDec 2, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING A REVERSE TOTAL SHOULDER ARTHROPLASTY, THE CONNECTION PIECE OF ONE (1) 2.8MM GLENOID DRILL SHAFT CRACKED WHILE USING IT INSIDE PATIENT. THERE WAS 2 PIECES THAT WERE RETRIEVED USING TWEEZERS INSIDE THE PATIENT. EVERYTHING WAS RETRIEVED AND TAKEN OUT. THE PROCEDURE WAS PERFORMED, 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 23693378 ↗MalfunctionMay 21, 2025Break; Break
IT WAS REPORTED THAT DURING A TOTAL REVERSE REVISION SHOULDER ONE (1) TSS HEAD CUTTING TEMPLATE ROD. 2.5 BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22067376 ↗MalfunctionMay 9, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING A REVISION TOTAL SHOULDER ARTHROPLASTY, THE SURGEON MALLETED OFF ONE (1) BODY SEPARATOR FROM THE SHAFT WHILE ATTEMPTING TO REMOVE THE GLENOSPHERE. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A SMITH & NEPHEW BACK-UP DEVICE. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21997366 ↗MalfunctionMay 2, 2025Break; Fracture; Break; Fracture
IT WAS REPORTED THAT, DURING A TSA SURGERY, ONE OF THE FLANGES BROKE OFF ON THE TIP OF ONE (1) 2.8MM GLENOID DRILL SHAFT. THEY WERE ALL RETRIEVED, NOTHING WAS LEFT INSIDE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21950571 ↗MalfunctionSep 9, 2024Break; Break
IT WAS REPORTED THAT, DURING INTERNAL FIXATION SURGERY, TWO (2) TSS HEAD CUTTING TEMPLATE ROD. 2.5 BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20170963 ↗MalfunctionMar 29, 2024Break; Fracture; Break; Fracture
IT WAS REPORTED THAT, DURING SURGERY, ONE (1) COMBO INSERTER IMPACTOR. L BROKE. IT REMAINS UNKNOWN HOW WAS THE PROCEDURE FINISHED OR IF THERE WAS A DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19006859 ↗MalfunctionJan 11, 2024Fracture; Fracture
IT WAS REPORTED THAT, DURING TSA SURGERY, ONE (1) COMBO INSERTER/IMPACTOR. M BROKE DURING THE CASE. NO X-RAYS AVAILABLE, ITEM DID NOT BROKE INSIDE PATIENT AND NO PIECES WERE LEFT IN PATIENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18490767 ↗
Other Smith & Nephew, Inc. products
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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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