AEQUALIS PRESS-FITRecalls & reported problems across all models
Tornier · 13 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 25
- Deaths reported
- 0
- Injuries reported
- 25
- Recalls
- 0
We found 13 models of AEQUALIS PRESS-FIT by Tornier in the FDA's device registry (GUDID). Together they are named in 25 adverse event reports in the FDA's MAUDE database, received between Sep 28, 2016 and Feb 6, 2026 — classified as 25 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported AEQUALIS PRESS-FIT problems
Device problems
- Adverse Event Without Identified Device or Use Problem20
- Device Dislodged or Dislocated3
- Loosening of Implant Not Related to Bone-Ingrowth3
- Migration1
Patient problems
- Patient Problem/Medical Problem19
- Implant Pain3
- Pain2
- Bacterial Infection1
- Inadequate Osseointegration1
- Loss of Range of Motion1
- Unspecified Infection1
AEQUALIS PRESS-FIT models
13 models, most reported first. Each model has its own page with its reports, recalls and device details.
- AEQUALIS PRESS-FIT DWB712PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED3 reports
- AEQUALIS PRESS-FIT DWB713PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED3 reports
- AEQUALIS PRESS-FIT DWB722PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED3 reports
- AEQUALIS PRESS-FIT DWB723PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED3 reports
- AEQUALIS PRESS-FIT DWB721PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED2 reports
- AEQUALIS PRESS-FIT DWB732PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED2 reports
- AEQUALIS PRESS-FIT DWB733PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED2 reports
- AEQUALIS PRESS-FIT DWB742PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED2 reports
- AEQUALIS PRESS-FIT DWB703PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- AEQUALIS PRESS-FIT DWB711PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED1 report
- AEQUALIS PRESS-FIT DWB724PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- AEQUALIS PRESS-FIT DWB734PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- AEQUALIS PRESS-FIT DWB744PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED1 report
Recent AEQUALIS PRESS-FIT adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, THE PATIENT HAD PAIN. IT WAS ALSO REPORTED. ENOVIS TEAM WERE USED FOR THEIR STEM ONCE THE AEQUALIS AND PERFORM PEGGED WAS REMOVED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Pain
MAUDE report 24278379 ↗InjuryNov 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, THE OLD PRESS FIT STEM AND CORTILOC GLENOID WERE REVISED DUE TO PAIN IN PATIENT. NO FURTHER PATIENT ADVERSE CONSEQUENCES REPORTED, REVISION WENT AS PLANNED.
Patient problems: Implant Pain
MAUDE report 23477660 ↗InjuryFeb 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT REQUIRED REVISION SURGERY DUE TO PAIN.
Patient problems: Implant Pain
MAUDE report 18767751 ↗InjuryJul 18, 2022Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration
PATIENT FELL OFF BICYCLE, NOW COMPLAINING OF SEVERE PAIN AND INABILITY TO USE ARM. XRAYS AND CT SHOW LOOSE GLENOID COMPONENT. THE ASPIRATION GREW OUT C. ACNES RE-OPERATION WITH COMPONENT CHANGE. PATIENT IS SCHEDULED FOR REVISION SURGERY.
Patient problems: Bacterial Infection; Implant Pain; Loss of Range of Motion
MAUDE report 15047290 ↗InjuryFeb 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2013, ''PRESS-FIT'' INITIAL SURGERY WAS PERFORMED. IN (B)(6) 2019, INFECTION WAS CONFIRMED IN THE AFFECTED AREA AFTER SURGERY.
Patient problems: Unspecified Infection
MAUDE report 13607068 ↗InjuryApr 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DR. (B)(6) EXPLANTED THE GLENOID, THE HUMERAL HEAD AND HUMERAL STEM. HE COMMENTED ON THE SIGNIFICANT WEAR OF THE GLENOID.
Patient problems: Patient Problem/Medical Problem
MAUDE report 9920220 ↗InjuryMay 15, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
"IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY DUE TO GROSS LOOSENING OF GLENOID COMPONENT, 10 YEARS AFTER PRIMARY SURGERY. SUBJECT ID: (B)(6)".
Patient problems: Patient Problem/Medical Problem
MAUDE report 8611451 ↗InjuryApr 12, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY DUE TO ASEPTIC GLENOID LOOSENING 11 YEARS AFTER PRIMARY SURGERY. SUBJECT ID: (B)(6).
Patient problems: Patient Problem/Medical Problem
MAUDE report 8508787 ↗InjuryJan 2, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
"IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY DUE TO LOOSENING/LYSIS 14 YEARS POST-OPERATIVE. SUBJECT ID: (B)(6)."
Patient problems: Patient Problem/Medical Problem
MAUDE report 8207828 ↗InjuryOct 19, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
"IT WAS REPORTED THAT A PATIENT HAD A REVISION SURGERY FOR LOOSENING/LYSIS 11 YEARS POST-OPERATIVE. (B)(6)."
Patient problems: Inadequate Osseointegration
MAUDE report 7984479 ↗InjurySep 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
"IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY FOR IMPLANT BREAKAGE (GLENOID IMPLANT) WITH PAIN (GLENOID WEAR, GLENOID IMPLANT BREAKAGE, ROTATOR CUFF INSUFFICIENCY, GLENOID BONE LOSS WERE ALL LISTED AS REASONS FOR REVISION. (B)(6).
Patient problems: Pain; Patient Problem/Medical Problem
MAUDE report 7845530 ↗InjuryApr 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
"IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY FOR GLENOID LOOSENING. PATIENT ID : (B)(6)".
Patient problems: Patient Problem/Medical Problem
MAUDE report 7467957 ↗InjuryApr 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY FOR ROTATOR CUFF INSUFFICIENCY 5 YEARS POST-OPERATIVE.
Patient problems: Patient Problem/Medical Problem
MAUDE report 7465270 ↗InjuryJan 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
"IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY DUE TO LOOSENING-LYSIS 9 YEARS POST-OP. PATIENT ID : (B)(6)".
Patient problems: Patient Problem/Medical Problem
MAUDE report 7159705 ↗InjuryNov 21, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY DUE TO LOOSENING-LYSIS 13 YEARS POST-OP. PATIENT ID : (B)(6).
Patient problems: Patient Problem/Medical Problem
MAUDE report 7048079 ↗
Other Tornier products
- Tornier Flex Shoulder System91 models · 791 reports
- Blueprint Mixed Reality8 models · 0 reports · 9 recalls
- AEQUALIS REVERSED II46 models · 405 reports
- AEQUALIS REVERSED41 models · 258 reports
- FLEX SHOULDER SYSTEM35 models · 194 reports
- Tornier Perform Anatomic Glenoid25 models · 81 reports
- Aequalis Ascend Flex30 models · 79 reports
- AEQUALIS15 models · 56 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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