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AEQUALIS™ PerFORM Reversed DWJ023Recalls & reported problems

Tornier, Inc. · Class 2 · Implant

All models of AEQUALIS PerFORM Reversed (17)

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 00846832061945), received between Aug 24, 2021 and Aug 24, 2021 — 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.

  • InjuryAug 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED SUDDEN ONSET OF INCREASING PAIN IN THE LEFT SHOULDER AND LOSS OF ACTIVE MOTION. IT WAS FOUND ON CT SCANS THAT THE PATIENT SUFFERED AN ACROMION FRACTURE. THE IMPLANTS ARE STILL IN GOOD POSITION. PATIENT WAS INSTRUCTED TO WEAR A SLING FOR 1 MONTH & TAKE (B)(6). PATIENT RETURNED TO THE CLINIC ONE MONTH LATER AND WAS IMPROVING.

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

    MAUDE report 12362695 ↗

Other PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED devices

All PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED devices →

Sources and updates

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