AEQUALIS PerFORM ReversedRecalls & reported problems across all models
Tornier, Inc. · 17 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 28
- Deaths reported
- 0
- Injuries reported
- 25
- Recalls
- 0
We found 17 models of AEQUALIS PerFORM Reversed by Tornier, Inc. in the FDA's device registry (GUDID). Together they are named in 28 adverse event reports in the FDA's MAUDE database, received between Apr 22, 2021 and May 19, 2026 — classified as 25 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (7 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 Reversed problems
Device problems
- Adverse Event Without Identified Device or Use Problem10
- Insufficient Device Problem Information7
- Device Dislodged or Dislocated5
- Loss of Osseointegration3
- Unstable3
- Break2
- Loosening of Implant Not Related to Bone-Ingrowth1
- Material Fragmentation1
Patient problems
- Pain10
- Bone Fracture(s)6
- Unspecified Infection5
- Osteolysis4
- Joint Laxity3
- Failure of Implant2
- Joint Dislocation2
- Loss of Range of Motion2
AEQUALIS PerFORM Reversed models
17 models, most reported first. Each model has its own page with its reports, recalls and device details.
- AEQUALIS™ PerFORM Reversed DWJ401shoulder prosthesis, reverse configuration4 reports
- AEQUALIS™ PerFORM Reversed DWJ012shoulder prosthesis, reverse configuration4 reports
- AEQUALIS™ PerFORM Reversed DWJ013PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED3 reports
- AEQUALIS™ PerFORM Reversed DWJ338shoulder prosthesis, reverse configuration2 reports
- AEQUALIS™ PerFORM Reversed DWJ022PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED2 reports
- AEQUALIS™ PerFORM Reversed DWJ024shoulder prosthesis, reverse configuration2 reports
- AEQUALIS™ PerFORM Reversed DWJ530shoulder prosthesis, reverse configuration1 report
- AEQUALIS™ PerFORM Reversed DWJ722PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- AEQUALIS™ PerFORM Reversed DWJ726PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- AEQUALIS™ PerFORM Reversed DWJ738PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- AEQUALIS™ PerFORM Reversed DWJ746PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- AEQUALIS™ PerFORM Reversed DWJ411shoulder prosthesis, reverse configuration1 report
- AEQUALIS™ PerFORM Reversed DWJ014PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- AEQUALIS™ PerFORM Reversed DWJ023PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- AEQUALIS™ PerFORM Reversed DWJ033shoulder prosthesis, reverse configuration1 report
- AEQUALIS™ PerFORM+ Reversed DWJ512shoulder prosthesis, reverse configuration1 report
- AEQUALIS™ PerFORM+ Reversed DWJ505shoulder prosthesis, reverse configuration1 report
Recent AEQUALIS PerFORM Reversed adverse event reports
The 15 most recent reports across all models, 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 ↗InjuryMar 5, 2026Unstable; Loss of Osseointegration
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) 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024 A PATIENT REQUIRED REVISION SURGERY DUE TO PERIPROSTHETIC FRACTURE, INSTABILITY AND ASEPTIC GLENOID LOOSENING WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Bone Fracture(s); Joint Laxity; Osteolysis
MAUDE report 24517749 ↗InjuryMar 5, 2026Unstable; Loss of Osseointegration
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) 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024 A PATIENT REQUIRED REVISION SURGERY DUE TO PERIPROSTHETIC FRACTURE, INSTABILITY AND ASEPTIC GLENOID LOOSENING WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Bone Fracture(s); Joint Laxity; Osteolysis
MAUDE report 24517748 ↗InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem
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 MAY. 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Unspecified Infection
MAUDE report 24413931 ↗InjuryJan 13, 2026Loss of Osseointegration
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 ASEPTIC LOOSENING GLENOID, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Osteolysis
MAUDE report 24052308 ↗InjuryDec 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
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 INFECTION.
Patient problems: Unspecified Infection
MAUDE report 23687370 ↗InjuryDec 1, 2025Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated
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 INSTABILITY, DISLOCATION & SUBLUXATION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Joint Laxity; Subluxation
MAUDE report 23686331 ↗InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
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 A PATIENT REQUIRED REVISION SURGERY DUE TO PERIPROSTHETIC FRACTURE, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Bone Fracture(s)
MAUDE report 23348099 ↗InjuryOct 9, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
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) 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024 A PATIENT REQUIRED REVISION SURGERY DUE TO GLENOID IMPLANT WEAR AND DISLOCATION/SUBLUXATION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Joint Dislocation; Subluxation
MAUDE report 23255294 ↗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 ↗InjuryApr 21, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
THE CUSTOMER REPORTED THAT : "I HAVE A PATIENT WHO HAS A PROBLEM WITH A PLATE WHICH IS MOBILE ON THE SHAFT OF A REVERSE SHOULDER PROSTHESIS. CLINICAL CONTEXT: PERSISTENT PAINFUL EPISODE SINCE APRIL 2024 WITH NO IMPROVEMENT, OR EVEN DETERIORATION. THE ICONOGRAPHY SHOWS A CHANGE IN THE RELATIONSHIP BETWEEN THE GLENOSPHERE AND THE PLATINUM, SUGGESTING A PROBLEM WITH THE MORSE TAPER."
Patient problems: Pain
MAUDE report 21876455 ↗InjuryApr 21, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
THE CUSTOMER REPORTED THAT : "I HAVE A PATIENT WHO HAS A PROBLEM WITH A PLATE WHICH IS MOBILE ON THE SHAFT OF A REVERSE SHOULDER PROSTHESIS. CLINICAL CONTEXT: PERSISTENT PAINFUL EPISODE SINCE APRIL 2024 WITH NO IMPROVEMENT, OR EVEN DETERIORATION. THE ICONOGRAPHY SHOWS A CHANGE IN THE RELATIONSHIP BETWEEN THE GLENOSPHERE AND THE PLATINUM, SUGGESTING A PROBLEM WITH THE MORSE TAPER."
Patient problems: Pain
MAUDE report 21876448 ↗InjuryApr 21, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
THE CUSTOMER REPORTED THAT : "I HAVE A PATIENT WHO HAS A PROBLEM WITH A PLATE WHICH IS MOBILE ON THE SHAFT OF A REVERSE SHOULDER PROSTHESIS. CLINICAL CONTEXT: PERSISTENT PAINFUL EPISODE SINCE (B)(6) 2024 WITH NO IMPROVEMENT, OR EVEN DETERIORATION. THE ICONOGRAPHY SHOWS A CHANGE IN THE RELATIONSHIP BETWEEN THE GLENOSPHERE AND THE PLATINUM, SUGGESTING A PROBLEM WITH THE MORSE TAPER."
Patient problems: Pain
MAUDE report 21875477 ↗InjuryApr 21, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
THE CUSTOMER REPORTED THAT : "I HAVE A PATIENT WHO HAS A PROBLEM WITH A PLATE WHICH IS MOBILE ON THE SHAFT OF A REVERSE SHOULDER PROSTHESIS. CLINICAL CONTEXT: PERSISTENT PAINFUL EPISODE SINCE (B)(6) 2024 WITH NO IMPROVEMENT, OR EVEN DETERIORATION. THE ICONOGRAPHY SHOWS A CHANGE IN THE RELATIONSHIP BETWEEN THE GLENOSPHERE AND THE PLATINUM, SUGGESTING A PROBLEM WITH THE MORSE TAPER."
Patient problems: Pain
MAUDE report 21875476 ↗InjuryApr 21, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
THE CUSTOMER REPORTED THAT : "I HAVE A PATIENT WHO HAS A PROBLEM WITH A PLATE WHICH IS MOBILE ON THE SHAFT OF A REVERSE SHOULDER PROSTHESIS. CLINICAL CONTEXT: PERSISTENT PAINFUL EPISODE SINCE APRIL 2024 WITH NO IMPROVEMENT, OR EVEN DETERIORATION. THE ICONOGRAPHY SHOWS A CHANGE IN THE RELATIONSHIP BETWEEN THE GLENOSPHERE AND THE PLATINUM, SUGGESTING A PROBLEM WITH THE MORSE TAPER."
Patient problems: Pain
MAUDE report 21875475 ↗
Other Tornier, Inc. products
- Tornier Perform Reversed Glenoid41 models · 515 reports · 1 recall
- Tornier Perform40 models · 290 reports · 1 recall
- TORNIER PERFORM HUMERAL SYSTEM68 models · 190 reports · 1 recall
- Tornier HRS40 models · 176 reports · 1 recall
- Tornier Perform Reversed Augmented Glenoid8 models · 121 reports · 1 recall
- AEQUALIS FLEX REVIVE24 models · 70 reports · 2 recalls
- Latitude - Elbow35 models · 147 reports
- Tornier Latitude7 models · 14 reports · 1 recall
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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