AEQUALIS™ PerFORM Reversed DWJ013Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00846832061907), received between Apr 22, 2021 and May 19, 2026 — classified as 2 injuries, 1 malfunction.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Device Dislodged or Dislocated1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- Unspecified Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 19, 2026Device Dislodged or Dislocated
THE PROCEDURE TOOK PLACE DUE TO CHRONIC DISLOCATION. ONCE THE SURGEON GOT EXPOSURE, THE TRAY AND POLY WERE REMOVED AND THE POLY HAD MEDIAL WEAR.
Patient problems: Insufficient Information
MAUDE report 25217219 ↗InjuryAug 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
POST-OPERATIVE COMPLICATION : INFECTION . RE-OPERATION WITH COMPONENT CHANGE ON THE (B)(6) 2021 (NO INFORMATION REGARDING THE EXACT DEVICES REMOVED). IV ANTIBIOTICS, CEMENT ANTIBIOTIC SPACER ADDED.
Patient problems: Unspecified Infection
MAUDE report 12297947 ↗MalfunctionApr 22, 2021Break; Break
ALLEGEDLY, THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON THE SHOULDER. THE SCREW OF THE GLENOSPHERE WAS JAMMED AND THE SURGEON WAS NOT ABLE TO ADVANCE IT AND PLACE IT INTO THE BASEPLATE. BY TRYING TO ADVANCE THE SCREW A PIECE BROKE (PICTURES ATTACHED). SURGEON HAD TO PROCEED WITH A SMALLER SIZE GLENOSPHERE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11711480 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page