PERFORM™ HUMERAL SYSTEM DWT4393Recalls & reported problems
Tornier, Inc. · Class 2 · Implant
- 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 00846832078639), received between Nov 26, 2025 and Nov 26, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Unstable” (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.
Reports received per month
Most reported problems
Device problems
- Unstable1
Patient problems
- Joint Impingement1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 26, 2025Unstable; Unstable
SUBJECT: (B)(6) PERFORM FRACTURE STUDY. INSTABILITY ¿ DYNAMIC. SUBJECT CONTACTED CLINIC ON (B)(6) 2025 WITH REPORTS OF ATRAUMATIC INSTABILITY AND PAIN. SHE WAS SEEN IN CLINIC ON (B)(6) 2025. X-RAYS AND CT SCAN SHOWED MILD NOTCHING BUT NO OTHER ABNORMALITIES. NO DOCUMENTED DISLOCATIONS.
Patient problems: Joint Impingement; Pain
MAUDE report 23654534 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.