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Titan™ IMP096006401Recalls & reported problems

Ascension Orthopedics, Inc. · Titan™ Reverse Shoulder System The Glenoid Baseplate Impactor is used to properly fit the implant and/or trial into the prepared cavity. · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780245650), received between Oct 19, 2022 and Oct 19, 2022 — classified as 1 malfunction.

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. How this data works · Data updated Oct 13, 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.

  • 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 ↗

Other IMPACTOR devices

All IMPACTOR devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.