PERFORM™ HUMERAL SYSTEM DWS1363Recalls & 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 00846832078004), received between Feb 25, 2026 and Feb 25, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Off-Label Use” (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
- Off-Label Use1
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 25, 2026Off-Label Use
WHILE COVERING A REVERSE SHOULDER PROCEDURE A 1/2 36+3 POLY WAS OPENED AND IMPLANTED. THIS DID NOT MATCH THE 39 GLENOSPHERE THAT WAS USED ON THE GLENOID. IT WAS DISCOVERED HOURS AFTER THE SURGERY. THE PATIENT WAS TAKEN BACK IN THE FOLLOWING MORNING TO PUT THE CORRECT MATCHING IMPLANT IN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24448055 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.