TitanRecalls & reported problems across all models
Ascension Orthopedics, Inc. · 19 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 39
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 0
We found 19 models of Titan by Ascension Orthopedics, Inc. in the FDA's device registry (GUDID). Together they are named in 39 adverse event reports in the FDA's MAUDE database, received between May 4, 2022 and Sep 10, 2025 — classified as 4 injuries, 35 malfunctions.
The most frequently reported specific device problem is “Fracture” (22 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 problems
Device problems
- Fracture22
- Break16
- Detachment of Device or Device Component2
- Material Deformation2
Patient problems
- No Clinical Signs, Symptoms or Conditions38
- Foreign Body In Patient1
Titan models
19 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Titan™ IMP-0961-064-SORTHOPEDIC MANUAL SURGICAL INSTRUMENT14 reports
- TITAN™ SZR-0926-030-010TEMPLATE3 reports
- TITAN™ SZR-0926-030-020TEMPLATE3 reports
- Titan™ TRL096002CPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED2 reports
- Titan™ ROD-0923-040-001ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- Titan™ IMP-0926-030-02AIMPACTOR2 reports
- Titan™ DTL096008LRGTEMPLATE1 report
- Titan™ HDL096006501ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- Titan™ INS096004802TEMPLATE1 report
- Titan™ DGB096008STDORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- Titan™ IMP096006401IMPACTOR1 report
- Titan™ IMP096006601IMPACTOR1 report
- Titan™ IMS096007001ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- Titan™ SCR096006301ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- Titan™ SET189D007ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- TITAN™ SZR-0926-030-000TEMPLATE1 report
- TITAN™ SZR-0926-030-030TEMPLATE1 report
- Titan™ IMP-0926-030-00AIMPACTOR1 report
- Titan™ IMP-0926-030-01AIMPACTOR1 report
Recent Titan adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 10, 2025Break; Break
IT WAS REPORTED THAT, DURING A TSA REVISION SURGERY, TWO (2) HUMERAL BODY INSERTER/ EXTRACTOR KNOB BROKE WHILE TRYING TO EXTRACT THE IMPLANT. 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 23022757 ↗InjuryFeb 27, 2023Fracture; Fracture
IT WAS REPORTED THAT, DURING A ACL SURGERY WHILE REMOVING THE LOCKING CAPS, THE PRONGS OF THE SLOTTED T-15 STAR DRIVER SCREW + CAP BROKE OFF INTO THE LOCKING CAP THAT WAS INSERTED INTO THE PATIENT BODY. NO PIECES FELL INTO PATIENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16449265 ↗MalfunctionDec 26, 2022Fracture; Fracture
IT WAS REPORTED THAT, DURING USE, THE BLACK TIP ON A RSS GLENOID BASEPLATE IMPACTOR-S BROKE OFF DURING INSERTION OF THE BASEPLATE. HOWEVER, ALL PIECES WERE RECOVERED. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16048707 ↗MalfunctionDec 26, 2022Fracture; Fracture
IT WAS REPORTED THAT DURING A SHOULDER ARTHROPLASTY, THE TIP OF THE RSS GLENOID BASEPLATE IMPACTOR-S DEVICE WAS FOUND TO BE BROKEN. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO PIECES FELL IN PATIENT. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16048651 ↗MalfunctionDec 9, 2022Fracture; Fracture
IT WAS REPORTED THAT, DURING SHOULDER SURGERY, THE TIP ON A FIN-LOCK SIZER. M BROKE OUTSIDE OF THE PATIENT ON BACK TABLE. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. THE PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15948743 ↗MalfunctionDec 9, 2022Fracture; Fracture
IT WAS REPORTED THAT, DURING SHOULDER SURGERY, THE TIP ON A FIN-LOCK SIZER. S BROKE OUTSIDE OF THE PATIENT ON BACK TABLE. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. THE PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15948734 ↗MalfunctionNov 12, 2022Fracture; Fracture
IT WAS REPORTED THAT, DURING A TOTAL SHOULDER SURGERY, ONE OF THE ARMS ON A COMBO INSERTER/IMPACTOR. M BROKE OFF. NO PIECES FELL INSIDE PATIENT. THE PROCEDURE WAS COMPLETED, 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 15785852 ↗MalfunctionOct 26, 2022Break; Break
IT WAS REPORTED THAT, DURING A REVERSE SHOULDER REPLACEMENT SURGERY, THE PLASTIC END OF THE RSS GLENOID BASEPLATE IMPACTOR-S BROKE WHILE USING. NO PIECES FELL INSIDE OF THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15674243 ↗MalfunctionOct 25, 2022Break; Break
IT WAS REPORTED THAT, DURING SURGERY, THE ATTACHMENT RUB OF THE FIN-LOCK SIZER. L BROKE OFF. NO PIECES FELL INSIDE OF THE PATIENT. IT IS UNKNOWN HOW THE SURGERY WAS COMPLETED. NO DELAY WAS REPORTED. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15669990 ↗MalfunctionOct 19, 2022Fracture; Fracture
IT WAS REPORTED THAT, DURING USE, THE PLASTIC PORTION ON THE HEAD OF A GLENOID BASEPLATE IMPACTOR MOD BROKE OFF. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. IT REMAINS UNCLEAR IF THE PATIENT WAS HARMED AS A CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15636162 ↗MalfunctionOct 19, 2022Fracture; Fracture
IT WAS REPORTED THAT, TWO (2) FIN-LOCK SIZER. XS WERE DISCOVERED TO BE BROKEN. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15635793 ↗MalfunctionOct 7, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE IMPACTION STAND OF A STEM IMPACTION STAND MOD WAS DETACHED MAKING IT UNUSABLE. IT APPEARS AS THOUGH THE SCREW STRIPPED FROM THE BASE. THE PROCEDURE WAS COMPLETED USING A S+N BACK-UP DEVICE. SURGERY WAS COMPLETED WITH A NON-SIGNIFICANT DELAY. PATIENT WAS NOT HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15564421 ↗MalfunctionOct 4, 2022Fracture; Fracture
IT WAS REPORTED THAT, DURING A SHOULDER SURGERY, THE THREADED TIP OF A TSS HEAD CUTTING TEMPLATE ROD. 2.5 BROKE OFF WHILE TRYING TO SCREW IT INTO THE INSERTER/IMPACTOR. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15537892 ↗MalfunctionSep 22, 2022Fracture; Fracture
IT WAS REPORTED THAT, DURING A RSA SURGERY, THE THREADED TIP OF A VERSION ROD BROKE OFF WHILE TRYING TO SCREW IT INTO THE INSERTER/IMPACTOR. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15467350 ↗MalfunctionSep 2, 2022Fracture; Fracture
IT WAS REPORTED THAT DURING A REVERSE SHOULDER SYSTEM-S PROCEDURE, THE PLASTIC INSERT OF A HUMERAL REAMER GUIDE BODY DEF. STD MOD BROKE OFF IN BONE. SURGERY WAS RESUMED AFTER A NON-SIGNIFICANT DELAY. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THE PATIENT OUTCOME IS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15349604 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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