AEQUALIS™ PerFORM Reversed DWJ024Recalls & 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00846832061952), received between Sep 16, 2021 and Sep 18, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Failure of Implant1
- Loss of Range of Motion1
- Osteolysis1
- Pain1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT; A PATIENT WAS BOOKING IN FOR A REVISION PROCEDURE DUE TO ONGOING PAIN AND STIFFNESS. DURING THE DISSECTION LOTS OF FLUID/ PUSS WAS SEEN AND THE DECISION WAS MADE TO DO A 2 STAGE PROCEDURE TO CLEAR THE INFECTION. ANOTHER REVISION PROCEDURE WILL BE NEEDED AFTER THE INFECTION HAS CLEARED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Loss of Range of Motion; Pain; Unspecified Infection
MAUDE report 23084456 ↗InjurySep 16, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO LOOSENING/LYSIS OF THE IMPLANT.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 12484529 ↗
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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