Aequalis Ascend FlexRecalls & reported problems across all models
Tornier · 30 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 79
- Deaths reported
- 0
- Injuries reported
- 68
- Recalls
- 0
We found 30 models of Aequalis Ascend Flex by Tornier in the FDA's device registry (GUDID). Together they are named in 79 adverse event reports in the FDA's MAUDE database, received between Jul 7, 2016 and Mar 10, 2026 — classified as 68 injuries, 11 malfunctions.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (10 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 Ascend Flex problems
Device problems
- Adverse Event Without Identified Device or Use Problem49
- Device Contaminated During Manufacture or Shipping10
- Device Dislodged or Dislocated9
- Loosening of Implant Not Related to Bone-Ingrowth2
- Patient Device Interaction Problem2
- Biocompatibility1
- Contamination1
- Insufficient Device Problem Information1
Patient problems
- Patient Problem/Medical Problem31
- Unspecified Infection22
- Bone Fracture(s)9
- Joint Dislocation9
- Pain6
- Osteolysis5
- Muscle Weakness/Atrophy4
- Fall3
Aequalis Ascend Flex models
30 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Aequalis™ Ascend™ Flex DWF601BPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED8 reports
- Aequalis™ Ascend™ Flex DWF604BPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED8 reports
- Aequalis™ Ascend™ Flex DWF602BPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED7 reports
- Aequalis™ Ascend™ Flex DWF603BPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED6 reports
- Aequalis™ Ascend™ Flex DWF605APROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED4 reports
- Aequalis™ Ascend™ Flex DWF606BPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED4 reports
- Aequalis™ Ascend™ Flex DWF607APROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED4 reports
- Aequalis™ Ascend™ Flex DWF607BPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED4 reports
- Aequalis™ Ascend™ Flex DWF613BPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED3 reports
- Aequalis™ Ascend™ Flex DWF712BPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED3 reports
- Aequalis™ Ascend™ Flex DWF601APROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED2 reports
- Aequalis™ Ascend™ Flex DWF603APROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED2 reports
- Aequalis™ Ascend™ Flex DWF603CPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED2 reports
- Aequalis™ Ascend™ Flex DWF604APROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED2 reports
- Aequalis™ Ascend™ Flex DWF605BPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED2 reports
- Aequalis™ Ascend™ Flex DWF702BPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED2 reports
- Aequalis™ Ascend™ Flex DWF706APROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED2 reports
- Aequalis™ Ascend™ Flex DWF708APROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED2 reports
- Aequalis™ Ascend™ Flex DWF602CPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Aequalis™ Ascend™ Flex DWF604CPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Aequalis™ Ascend™ Flex DWF605CPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Aequalis™ Ascend™ Flex DWF606APROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Aequalis™ Ascend™ Flex DWF612BPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Aequalis™ Ascend™ Flex DWF614APROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Aequalis™ Ascend™ Flex DWF614BPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Aequalis™ Ascend™ Flex DWF615BPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Aequalis™ Ascend™ Flex DWF617APROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Aequalis™ Ascend™ Flex DWF708BPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Aequalis™ Ascend™ Flex DWF714BPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Aequalis™ Ascend™ Flex DWF716BPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
Recent Aequalis Ascend Flex adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryMar 10, 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 (B)(6) 2026. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2025 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Unspecified Infection
MAUDE report 24556887 ↗InjuryJan 28, 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 (B)(6) 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 24197583 ↗InjuryJan 5, 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 (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, PERIPROSTHETIC FRACTURE & LYSIS- GLENOID, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Bone Fracture(s); Osteolysis; Unspecified Infection
MAUDE report 23957850 ↗InjuryDec 29, 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) 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2018 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Unspecified Infection
MAUDE report 23905585 ↗InjuryDec 24, 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 WITH THE TORNIER SHOULDER SYSTEM. THE REPORT DETAILS ANALYSIS PROVIDED FOR 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 IMPINGEMENT & LYSIS - GLENOID, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. REVISION PROCEDURE TYPE: SINGLE STAGE REVISION (INCLUDES DAIR WITH MODULAR EXCHANGE AND MODULAR EXCHANGE FOR INDICATIONS OTHER THAN INFECTION)
Patient problems: Joint Impingement; Osteolysis
MAUDE report 23886846 ↗InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, REVISION SURGERY WAS PERFORMED. 2 STAGE PROCEDURE AS LIKELY TO BE INFECTED. PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2022 WITH ASCEND FLEX AND REVERSE II IMPLANTS. ALL IMPLANTS WERE REMOVED AND PICTURED. A CEMENT SPACER WAS PLACED IN.IT WAS FURTHER REPORTED, THE PATIENT HAD PAIN AND SURGEON ORDERED X-RAYS (THESE WERE ATTACHED IN MY SUBMISSION) AND SURGEON NOTICED BONE REABSORPTION. DID NOT EXPECT INFECTION AS NO PATHOLOGY TESTS INDICATED IT. HOWEVER IN REVISION SURGEON THERE WAS STRONG EVIDENCE OF INFECTION WITH PUS AND INFECTED TISSUE.
Patient problems: Implant Pain; Osteolysis; Unspecified Infection
MAUDE report 23870699 ↗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 PERIPROSTHETIC FRACTURE.
Patient problems: Bone Fracture(s)
MAUDE report 23687373 ↗InjuryOct 9, 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) 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2021 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, ASEPTIC GLENOID LOOSENING, GLENOID LYSIS AND DISLOCATION/SUBLUXATION WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Inadequate Osseointegration; Medical device site infection; Osteolysis; Subluxation
MAUDE report 23255295 ↗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 23084454 ↗InjuryMay 20, 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 WITH THE TORNIER SHOULDER SYSTEM. THE REPORT DETAILS ANALYSIS PROVIDED FOR PROCEDURES PERFORMED BETWEEN DECEMBER 2013 ¿ FEBRUARY 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2023, A PATIENT REQUIRED REVISION SURGERY DUE TO INSTABILITY, NATIVE GLENOID EROSION, AND SUBLUXATION/DISLOCATION WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Erosion; Joint Laxity; Subluxation
MAUDE report 22056355 ↗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 21876453 ↗InjuryMar 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A REVISION SURGERY WAS PLANNED TO BE PERFORMED USING THE BLUEPRINT PLANNING FEATURE. THE PATIENT IS 59 YEAR OLD FEMALE HAS RHEUMATOID ARTHRITIS AND HAD A SIGNIFICANT FALL AFTER SURGERY THAT RESULTED IN IMPLANT LOOSENING.
Patient problems: Fall; Rheumatoid Arthritis
MAUDE report 21393814 ↗InjuryJan 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT FELL RESULTING IN A PERIPROSTHETIC FRACTURE. ALL IMPLANTED COMPONENTS WERE REMOVED, AND A REVERSE PROSTHESIS WAS PLACED. NO IMAGES WERE PROVIDED. THE EXPLANTED IMPLANTS WERE NOT AVAILABLE FOR EVALUATION PER HOSPITAL POLICY REQUIRING DISPOSAL OF EXPLANTED ITEMS.
Patient problems: Bone Fracture(s); Fall
MAUDE report 21242119 ↗InjuryFeb 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT HAD BEEN EXPERIENCING INCREASING PAIN AND DYSFUNCTION. DIAGNOSTIC WORK UP INCLUDED AN ASPIRAITON OF THE LEFT SHOULDER JOINT WHICH WAS POSITIVE. SUBJECT UNDERWENT REMOVAL OF IMPLANTS AND PLACEMENT OF ANTIBIOTIC SPACER. PATIENT ID: (B)(6).
Patient problems: Unspecified Infection
MAUDE report 13607040 ↗
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
- AEQUALIS15 models · 56 reports
- Blueprint4 models · 0 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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