AEQUALIS PerFORMRecalls & reported problems across all models
Tornier · 16 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 29
- Deaths reported
- 0
- Injuries reported
- 29
- Recalls
- 0
We found 16 models of AEQUALIS PerFORM by Tornier in the FDA's device registry (GUDID). Together they are named in 29 adverse event reports in the FDA's MAUDE database, received between Aug 1, 2016 and Nov 28, 2025 — classified as 29 injuries.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (5 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 PerFORM problems
Device problems
- Adverse Event Without Identified Device or Use Problem18
- Loosening of Implant Not Related to Bone-Ingrowth5
- Device Dislodged or Dislocated4
- Break2
- Loss of Osseointegration1
- Material Erosion1
- Naturally Worn1
Patient problems
- Patient Problem/Medical Problem16
- Pain7
- Joint Dislocation4
- Muscle Weakness/Atrophy4
- Joint Laxity2
- Unspecified Infection2
- Bone Fracture(s)1
- Failure of Implant1
AEQUALIS PerFORM models
16 models, most reported first. Each model has its own page with its reports, recalls and device details.
- AEQUALIS™ PerFORM DWE301PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED4 reports
- AEQUALIS™ PerFORM DWE313PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED3 reports
- AEQUALIS™ PerFORM DWE401PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED3 reports
- AEQUALIS™ PerFORM DWE411PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED3 reports
- AEQUALIS™ PerFORM DWE303PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED2 reports
- AEQUALIS™ PerFORM DWE321PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED2 reports
- AEQUALIS™ PerFORM DWE421PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED2 reports
- AEQUALIS™ PerFORM DWE423PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED2 reports
- AEQUALIS™ PerFORM DWE302PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- AEQUALIS™ PerFORM DWE312PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- AEQUALIS™ PerFORM DWE412PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- AEQUALIS™ PerFORM DWE413PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- AEQUALIS™ PerFORM DWE502PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- AEQUALIS™ PerFORM DWE503PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- AEQUALIS™ PerFORM DWE511PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- AEQUALIS™ PerFORM DWE522PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
Recent AEQUALIS PerFORM adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryNov 28, 2025Naturally Worn; Naturally Worn
THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES PERFORMED UNTIL (B)(6) 2025. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2025 A PATIENT REQUIRED REVISION SURGERY DUE TO PERIPROSTHETIC FRACTURE & GLENOID IMPLANT WEAR, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Bone Fracture(s)
MAUDE report 23671481 ↗InjuryOct 28, 2025Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT, THE GLENOID IMPLANT WAS DISLOCATED. THE REVISION SURGERY INVOLVED REMOVING THE IMPLANT AND PERFORMING AN ILIAC BONE GRAFT.
Patient problems: Inadequate Osseointegration; Pain
MAUDE report 23405624 ↗InjuryFeb 12, 2021Adverse 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 DUE TO COMPONENT LOOSENING ON (B)(6) 2021. THE HUMERAL HEAD AND GLENOID COMPONENT WERE REMOVED. THE STEM WAS RETAINED. PATIENT ID: (B)(6)".
Patient problems: Joint Laxity
MAUDE report 11320945 ↗InjurySep 1, 2020Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth; Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth
AFTER THE INITIAL SURGERY OF AEQUALIS PERFORM GLENOID TSA ON (B)(6) 2019, THE GLENOID IMPLANT DISLODGED DUE TO LOOSENING. ON (B)(6) 2020, A REVISION SURGERY WAS PERFORMED. AFTER REMOVAL OF THE PEGGLENOID AND THE HEAD IMPLANT, THE 4B STEM WAS LEFT IN PLACE AND REPLACED WITH RSA. A NEW INSERT (DWF361B), TRAY (DWF510), BASE PLATE (DWD170) AND GLENOID SPHERE (DWD180) WERE USED.
Patient problems: Joint Dislocation
MAUDE report 10475987 ↗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 ↗InjuryMay 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2018, THE INITIAL SURGERY OF AEQUILES PERFORM GLENOID WAS PERFORMED. AT THIS TIME, BONE CYSTS WERE CONFIRMED IN THE GLENOID, BUT THE OPERATION WAS COMPLETED WITHOUT ANY PROBLEMS. DURING THE PERIODIC HEALTH EXAMINATION ON (B)(6) 2020, EVERSION AT THE AFFECTED PART WAS CONFIRMED. IT HAD A LITTLE PAIN TOO. ON (B)(6) 2020, SURGERY WAS COMPLETED BY REMOVING ONLY THE PEG GLENOID. THE STEM IMPLANT ON THE HUMERAL SIDE WAS NOT LOOSENED, BUT THE GLENOID WAS SLIGHTLY DEFORMED. THE SURGEON COMMENTED THAT HE WANTED TO KNOW IF THE CAUSE OF EVERSION WAS DUE TO INSTABILITY OF THE PEG GLENOID DUE TO LACK OF CEMENT.
Patient problems: Joint Dislocation; Pain
MAUDE report 10095464 ↗InjuryMay 6, 2020Adverse 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 5 MONTHS AFTER INITIAL SURGERY, DUE TO INFECTION. THE PATIENT ALSO HAD A HUMERAL FATIGUE FRACTURE DURING THE REVISION SURGERY. PATIENT ID: (B)(6).
Patient problems: Unspecified Infection
MAUDE report 10028422 ↗InjuryDec 23, 2019Adverse 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 DUE TO ROTATOR CUFF INSUFFICIENCY ASSOCIATED WITH PAIN AND LOSS OF RANGE OF MOTION 3 YEARS AFTER PRIMARY SURGERY. PATIENT ID: (B)(6)."
Patient problems: Loss of Range of Motion; Muscle Weakness/Atrophy; Pain
MAUDE report 9509315 ↗InjuryDec 11, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
"(B)(6) 2017, INITIAL SURGERY OF ''AEQUALIS PERFORM GLENOID'' WAS PERFORMED. AFTER THE SURGERY, THE PATIENT VISITED THE HOSPITAL SEVERAL TIMES, BUT THERE WAS NO ABNORMALITY. IN THE MEANTIME, HE FELL DOWN SEVERAL TIMES AND HAD AN X-RAY EXAMINATION IN (B)(6) 2019, BUT FOUND NO PROBLEM. (B)(6) 2019, THE PATIENT VISITED THE HOSPITAL FOR PAIN AND AFTER THE EXAMINATION, IT WAS CONFIRMED THAT THE GLENOID PEG HAD FALLEN OUT. (B)(6) 2019, REVISION SURGERY WAS PERFORMED. THE FOUR HOLES FOR THE GLENOID PEG LOOKED GOOD AND ONLY THE GLENOID PEG WAS FALLED OUT, BUT IT WASN'T DEFORMED OR DAMAGED. SINCE THE CAUSE WAS UNKNOWN, IT WAS JUDGED THAT THE PEG GLENOID SHOULD NOT BE ADDED AGAIN, AND THE SURGERY WAS COMPLETED AND THE GLENOID AREA WAS LEFT AS IT WAS."
Patient problems: Patient Problem/Medical Problem
MAUDE report 9450110 ↗InjuryOct 3, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
"IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY 2 YEARS AFTER PRIMARY SURGERY DUE TO INSTABILITY/DISLOCATION. PATIENT ID: (B)(6).
Patient problems: Joint Dislocation
MAUDE report 9153587 ↗InjurySep 17, 2019Adverse 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 DUE TO ANTEROSUPERIOR ESCAPE. STEM RETAINED FROM PREVIOUS SURGERY. ASCEND FLEX ANATOMIC TOTAL CONVERTED INTO ASCEND FLEX REVERSED. PATIENT ID: (B)(6)"
Patient problems: Muscle Weakness/Atrophy
MAUDE report 9079526 ↗InjuryJun 11, 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 1 YEAR AFTER PRIMARY SURGERY. SUBJECT ID: (B)(6)."
Patient problems: Patient Problem/Medical Problem
MAUDE report 8686364 ↗InjuryApr 17, 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 GLENOID COMPONENT LOOSENING AND ROTATOR CUFF DEFICIENCY 3 YEARS AFTER PRIMARY SURGERY. SUBJECT ID: (B)(6).
Patient problems: Patient Problem/Medical Problem
MAUDE report 8522315 ↗InjuryApr 8, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT UNDERWENT THE ASCEND TSA SURGERY ON (B)(6) 2018. HUMERAL DISLOCATION AND A RECURRENCE OF ROTATOR CUFF TEARS OCCURRED IN (B)(6) 2019 AND THE PATIENT STILL COMPLAINS OF PAIN. A REVISION SURGERY IS SCHEDULED ON (B)(6) 2019.
Patient problems: Joint Dislocation; Muscle Weakness/Atrophy; Patient Problem/Medical Problem
MAUDE report 8490965 ↗InjuryDec 14, 2018Break; Break
"IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY FOR GLENOID COMPONENT BREAKAGE 4 YEARS POST-OPERATIVE. SUBJECT ID: (B)(4)".
Patient problems: Patient Problem/Medical Problem
MAUDE report 8163900 ↗
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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