PERFORM™ HUMERAL SYSTEM DWT4423Recalls & 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 00846832078660), received between Nov 14, 2024 and Nov 14, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated1
- Unstable1
Patient problems
- Joint Laxity1
- Subluxation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 14, 2024Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated
AS REPORTED: "PHS STUDY SUBJECT: (B)(4). COMPLICATION DESCRIPTION: INSTABILITY/DISLOCATION. PATIENT HAS HAD CONTINUED INSTABILITY OF RIGHT RSA DESPITE FORMALIZED PT. PATIENT REVISED ON (B)(6) 2024".
Patient problems: Joint Laxity; Subluxation
MAUDE report 20683137 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.