FLEX SHOULDER SYSTEMRecalls & reported problems across all models

We found 35 models of FLEX SHOULDER SYSTEM by Tornier in the FDA's device registry (GUDID). Together they are named in 194 adverse event reports in the FDA's MAUDE database, received between Jun 15, 2016 and Feb 18, 2026 — classified as 181 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (57 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

Most reported FLEX SHOULDER SYSTEM problems

FLEX SHOULDER SYSTEM models

35 models, most reported first. Each model has its own page with its reports, recalls and device details.

• FLEX SHOULDER SYSTEM DWF361B

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  33 reports
• FLEX SHOULDER SYSTEM DWF510

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  31 reports
• FLEX SHOULDER SYSTEM DWF520

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  29 reports
• FLEX SHOULDER SYSTEM DWF500

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  14 reports
• FLEX SHOULDER SYSTEM DWF362B

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  10 reports
• FLEX SHOULDER SYSTEM DWF422B

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  10 reports
• Flex Shoulder System DWF391B

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  7 reports
• FLEX SHOULDER SYSTEM DWF361C

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  6 reports
• FLEX SHOULDER SYSTEM DWF043

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  5 reports
• FLEX SHOULDER SYSTEM DWF143

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  4 reports
• FLEX SHOULDER SYSTEM DWF148

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  4 reports
• FLEX SHOULDER SYSTEM DWF421B

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  4 reports
• FLEX SHOULDER SYSTEM DWF046

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  3 reports
• Flex Shoulder System DWF392B

  shoulder prosthesis, reverse configuration
  3 reports
• FLEX SHOULDER SYSTEM DWF501

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  3 reports
• FLEX SHOULDER SYSTEM DWF521

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  3 reports
• FLEX SHOULDER SYSTEM DWF041

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  2 reports
• FLEX SHOULDER SYSTEM DWF050

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  2 reports
• FLEX SHOULDER SYSTEM DWF141

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  2 reports
• FLEX SHOULDER SYSTEM DWF421C

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  2 reports
• FLEX SHOULDER SYSTEM DWF424B

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  2 reports
• FLEX SHOULDER SYSTEM DWF511

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  2 reports
• FLEX SHOULDER SYSTEM DWF052

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  1 report
• FLEX SHOULDER SYSTEM DWF146

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  1 report
• FLEX SHOULDER SYSTEM DWF341

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  1 report
• FLEX SHOULDER SYSTEM DWF361A

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  1 report
• FLEX SHOULDER SYSTEM DWF364B

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  1 report
• FLEX SHOULDER SYSTEM DWF365B

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  1 report
• Flex Shoulder System DWF391C

  shoulder prosthesis, reverse configuration
  1 report
• Flex Shoulder System DWF395B

  shoulder prosthesis, reverse configuration
  1 report
• FLEX SHOULDER SYSTEM DWF422A

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  1 report
• FLEX SHOULDER SYSTEM DWF425B

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  1 report
• FLEX SHOULDER SYSTEM DWF502

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  1 report
• FLEX SHOULDER SYSTEM DWF512

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  1 report
• Flex Shoulder System DWF356B

  PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
  1 report

Recent FLEX SHOULDER SYSTEM adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryFeb 18, 2026Unstable

  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 INSTABILITY, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Joint Laxity

  MAUDE report 24380585 ↗
• 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 23905990 ↗
• 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 23905579 ↗
• 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 REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES PERFORMED BETWEEN (B)(6) 2025 - (B)(6) 2025. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2025 A PATIENT REQUIRED REVISION SURGERY DUE TO UNEXPLAINED PAIN, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Pain

  MAUDE report 23687352 ↗
• InjuryNov 28, 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 & GLENOID IMPLANT WEAR, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Bone Fracture(s)

  MAUDE report 23671484 ↗
• 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 23255868 ↗
• 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)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 23255498 ↗
• 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 21875474 ↗
• 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 21875471 ↗
• InjuryMar 18, 2025Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  PATIENT HAS CONTINUED TO EXPERIENCE LAXITY, OCCASIONAL DISLOCATIONS OF HER AFFECTED SHOULDER JOINT, INCLUDING PAIN, POOR RANGE OF MOTION. SURGEON DECIDED DURING SURGERY TO AGAIN INCREASE GLENOSPHERE DIAMETER AND INCREASE HUMERAL REVERSE TRAY , AND AGAIN IMPLANT A RETENTIVE POLY INSERT. PROSTHESIS IMPLANTED, SHOULDER JOINT REDUCED AND FOUND TO BE STABLE THROUGH RANGE OF MOTION.

  Patient problems: Joint Dislocation; Joint Laxity; Loss of Range of Motion; Pain

  MAUDE report 21632342 ↗
• InjuryMar 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 21532906 ↗
• InjuryMar 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 21529599 ↗
• InjuryFeb 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PAIN IS TRAVELING AND IS SO SEVERE AT TIMES. ALL INTO NECK AND DOWN ARM. SURGERY IN 2016 GOT BETTER BUT 6 MONTHS AGO, MY ARM IS MUCH MORE PAINFUL. I HAVE 105 + 2 LOT OF MOBILITY IN IT. CAN'T AFFORD TO GO TO DR AND CHECKED. I AM ON. WAS DOING REALLY GOOD ON HEALING. 6 MONTHS AGO STARTED GETTING WEAKER. THE PAIN IS ALL THE WAY INTO NECK AND MY HAND IS NUMB AND TINGLING. ELBOW PAIN. CAN'T AFFORD TO GO TO DOCTOR.

  Patient problems: Pain

  MAUDE report 13607139 ↗
• InjuryFeb 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PAIN IS TRAVELING AND IS SO SEVERE AT TIMES. ALL INTO NECK AND DOWN ARM. SURGERY IN 2016 GOT BETTER BUT 6 MONTHS AGO, MY ARM IS MUCH MORE PAINFUL. I HAVE 105 + 2 LOT OF MOBILITY IN IT. CAN'T AFFORD TO GO TO DR AND CHECKED. I AM ON. WAS DOING REALLY GOOD ON HEALING. 6 MONTHS AGO STARTED GETTING WEAKER. THE PAIN IS ALL THE WAY INTO NECK AND MY HAND IS NUMB AND TINGLING. ELBOW PAIN. CAN'T AFFORD TO GO TO DOCTOR.

  Patient problems: Pain

  MAUDE report 13607073 ↗
• InjuryFeb 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY ON 09-MARCH-2016 FOR DEEP INFECTION AT 3 WEEKS POST-OP. STEM AND BASEPLATE RETAINED AS PART OF SINGLE STAGE I&D AND REVISION FOR INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 13607061 ↗

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
• Tornier Perform Anatomic Glenoid25 models · 81 reports
• Aequalis Ascend Flex30 models · 79 reports
• AEQUALIS15 models · 56 reports
• Blueprint4 models · 0 reports · 1 recall