Titan Reverse Shoulder System DTL-0960-08STDRecalls & reported problems
Smith & Nephew, Inc. · HUMERAL BODY TRIAL W/ DEFINITIVE STD MOD · Class 1
All models of Titan Reverse Shoulder System (18)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556863718), received between Feb 14, 2023 and Feb 14, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (1 report).
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.
Most reported problems
Device problems
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 14, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING A TOTAL SHOULDER CONVERSION TO A REVERSE SHOULDER, ONE (1) HUMERAL BODY TRIAL W/ DEFINITIVE STD MOD BROKE WHEN FITTING IT OVER THE STEM. THE PLACE THAT BROKE OFF IS THE BLACK PLASTIC TIP THAT COVERS OVER THE STEM THAT IS IMPLANTED INTO THE HUMERUS AND WAS STUCK ON TOP OF THE STEM. IT THEN HAD TO BE SPLIT IN TWO WITH AN ELEVATOR AND REMOVED WITH A KOCHER. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, WITH A CHANGE IN THE SURGICAL TECHNIQUE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16372250 ↗
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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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