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Titan™ TRL096002CRecalls & reported problems

Ascension Orthopedics, Inc. · The Concentric Glenosphere Trial is used to evaluate the size and fit of the implant. · Class 2

All models of Titan (19)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10381780235897), received between May 27, 2022 and Jun 6, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Device problems

  • Break1
  • Fracture1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 6, 2022Break; Break

    IT WAS REPORTED THAT, DURING SET UP, IT WAS NOTICED THAT THE GLENOSPHERE CON TRIAL 2MM MOD WAS BROKEN. PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14602213 ↗
  • MalfunctionMay 27, 2022Fracture; Fracture

    IT WAS REPORTED THAT, A GLENOSPHERE CON TRIAL 2MM MOD BROKE OFF. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14520146 ↗

Other PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED devices

All PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED devices →

Sources and updates

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