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PERFORM™ HUMERAL SYSTEM DWS2426Recalls & reported problems

Tornier, Inc. · Class 2 · Implant

All models of PERFORM HUMERAL SYSTEM (21)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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 00846832078134), received between Dec 9, 2022 and Dec 9, 2022 — classified as 1 injury.

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 18, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Bone Fracture(s)1
  • Loss of Range of Motion1
  • Pain1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryDec 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A PATIENT HAD A ACROMION STRESS FRACTURE. THE PATIENT DID NOT EXPERIENCE A DECREASE IN THE RANGE BUT HE EXPERIENCED AN INCREASE IN PAIN.

    Patient problems: Bone Fracture(s); Loss of Range of Motion; Pain

    MAUDE report 15950366 ↗

Other prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented devices

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Sources and updates

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