AEQUALIS™ PerFORM DWE423Recalls & reported problems
Tornier · Class 2 · Implant
All models of AEQUALIS PerFORM (16)
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 03700386937538), received between Jan 16, 2018 and Aug 27, 2020 — 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.
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
- Joint Laxity1
- 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.
InjuryAug 27, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
COMPONENT LOOSENING; PATIENT COMPLAINING OF SEVERE PAIN. XRAYS SHOW A LOOSE GLENOID COMPONENT. PATIENT WILL BE WORKED UP FOR INFECTION AND GET A CT SCAN AND LIKELY PLAN FOR A REVISION SURGERY. ONGOING ADVERSE EVENT.
Patient problems: Joint Laxity; Pain; Unspecified Infection
MAUDE report 10460198 ↗InjuryJan 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE SURGEON PREPARED THE GLENOID FOR AN L60 CORTILOC GLENOID AND THE TRIAL SEATED FLUSH WITH THE BONE. WHEN HE WENT TO SEAT THE FINAL IMPLANT, IT WOULD NOT SIT FLUSH WITH THE BONE. HE TRIED TO GET IT SEATED WITHOUT SUCCESS AND ULTIMATELY DECIDED TO PULL IT OUT AND IT CAME OUT FAIRLY EASILY. UPON INSPECTION, THE SURGEON OBSERVED THE INFERIOR-POSTERIOR PEG WAS BENT AND CONCLUDED THIS WAS THE ISSUE. THE SURGEON REMOVED THE CEMENT AND RE-PREPPED THE GLENOID FOR AN L50 WHICH ADDED 20 MINUTES APPROXIMATELY TO THE SURGERY.
Patient problems: Failure of Implant
MAUDE report 7193172 ↗
Other PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED devices
- DJO SURGICAL 508-32-204Encore Medical, L.P. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall544 reports
- Comprehensive Reverse Shoulder 010000589Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall142 reports
- DELTA XTEND 130738203Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED175 reports
- DJO SURGICAL 509-00-432Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall117 reports
- Alliance® SBGL3007Zimmer, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED162 reports
- DELTA XTEND 130760138Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED146 reports
- DELTA XTEND 130790030Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED132 reports
- DJO SURGICAL 509-00-436Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented124 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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