PERFORM™ HUMERAL SYSTEM DWS4360Recalls & 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 00846832078233), received between Aug 27, 2024 and Aug 27, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Osseointegration Problem” (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
- Osseointegration Problem1
Patient problems
- Joint Laxity1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 27, 2024Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT THE PATIENT, WHO HAD A HISTORY OF A FOUR-PART PROXIMAL HUMERUS FRACTURE, UNDERWENT REVERSE TOTAL SHOULDER ARTHROPLASTY. THE HUMERAL STEM BECAME LOOSE, WHICH WAS CONFIRMED BY RADIOGRAPHS. AS A RESULT, A REVISION SURGERY WAS PERFORMED TO REMOVE AND REPLACE THE LOOSE HUMERAL STEM WITH A DIFFERENT STEM THAT WAS NOT PART OF THE PERFORM FRACTURE SYSTEM.
Patient problems: Joint Laxity
MAUDE report 20081609 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.