AEQUALIS™ PerFORM Reversed DWJ338Recalls & reported problems
Tornier, Inc. · Class 2 · Implant
All models of AEQUALIS PerFORM Reversed (17)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00846832060979), received between Dec 20, 2021 and Dec 29, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Break1
- Material Fragmentation1
- Unraveled Material1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 29, 2021Material Fragmentation; Unraveled Material; Material Fragmentation; Unraveled Material
DURING THE CASE, UPON INSERTING THE SCREW, THE METAL STARTED UNRAVELING WITH EVERY TURN OF THE SCREW RESULTING IN THIS LONG METAL SHAVING THAT WAS STICKING OUT OF THE BASEPLATE. REMOVED THE SCREW AND METAL SHAVING. PUT IN ANOTHER SCREW TO REPLACE IT AND EVERYTHING WORKED OUT FINE. NO HARM TO THE PATIENT AND THE CASE WASN¿T DELAYED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13107445 ↗MalfunctionDec 20, 2021Break; Break
WHEN THE SURGEON WAS TIGHTENING THE SCREW, THE HEAD BROKE OFF. THE BROKEN PIECE WAS RECOVERED AND REMOVED FROM THE PATIENT, BUT THE OTHER PART OF THE SCREW IS STILL IN. THERE WAS NO ISSUE TO PATIENT NOR WAS THERE A DELAY IN SURGERY.
Patient problems: Foreign Body In Patient
MAUDE report 13047583 ↗
Other shoulder prosthesis, reverse configuration devices
- DJO SURGICAL 508-36-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration508 reports
- DJO SURGICAL 508-32-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration433 reports
- DJO SURGICAL 508-32-103Encore Medical, L.P. · shoulder prosthesis, reverse configuration421 reports
- DJO SURGICAL 509-00-036Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall259 reports
- DJO SURGICAL 508-32-104Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall203 reports
- DJO SURGICAL 509-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration233 reports
- DELTA XTEND 130760000Depuy (Ireland) · shoulder prosthesis, reverse configuration223 reports
- DJO SURGICAL 508-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration122 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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