FLEX SHOULDER SYSTEM DWF362BRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 03700386940538), received between Jun 21, 2016 and Feb 25, 2022 — classified as 10 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• 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 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED DISLOCATION CARRYING A POT AND THEN SELF-REDUCTION. SUBJECT ID:(B)(6).

  Patient problems: Joint Dislocation

  MAUDE report 11265240 ↗
• InjuryMay 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER THIS PATIENT HAD A ASCEND FLEX REVERSE INITIAL SURGERY ON (B)(6) 2019, INFECTION WAS FOUND IN THE AFFECTED AREA AND THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2019. THE INSERT, AND THE TRAY WAS NEWLY REPLACED. BUT HALF A YEAR LATER, INFECTION WAS FOUND IN THE AFFECTED AREA AGAIN. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2020. THE INSERT,THE TRAY, AND THE GLENOID SPHERE (IMPLANTED ON (B)(6) 2019) WAS NEWLY REPLACED, AND THE SURGERY WAS COMPLETED.

  Patient problems: Unspecified Infection

  MAUDE report 10074007 ↗
• InjuryMar 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD AN ACROMIAL FRACTURE (SCAPULAR SPINE STRESS FRACTURE) NOT PRESENT PRE-OP, 1 YEAR AFTER PRIMARY SURGERY. PATIENT ID: (B)(6)".

  Patient problems: Bone Fracture(s)

  MAUDE report 9882236 ↗
• InjuryDec 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DISASSOCIATION OF THE DISTAL STEM AND THE PROXIMAL BODY OF AEQUALIS ASCEND FLEX REVIVE COMPONENTS VISUALIZED ON POST-OP X-RAY. PRELIMINARY ANALYSIS SHOWS THAT THE ISSUE IS NOT RELATED TO AEQUALIS ASCEND FLEX COMPONENTS BUT RATHER TO AEQUALIS FLEX REVIVE COMPONENTS DISASSOCIATION (TORNIER INC COMPONENTS).

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 9430627 ↗
• InjuryDec 19, 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 DUE TO HUMERAL FRACTURE, 1 MONTH POST-OPERATIVE. SUBJECT ID: (B)(6)".

  Patient problems: Bone Fracture(s)

  MAUDE report 8178385 ↗
• InjuryFeb 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  "(B)(6) 2017: INITIAL RSA SURGERY WAS DONE. / (B)(6) 2017: GLENOID SPHERE DISLOCATION WAS FOUND. (THE PATIENT HAD BEEN UNABLE TO LIFT HER SHOULDER.) / (B)(6) 2017: GLENOID SPHERE, BASEPLATE, 4 SCREWS, INSERT AND TRAY WERE REMOVED. COMMENTS FROM SURGEON: THE PATIENT'S BONE DENSITY HAD BEEN VERY LOW WHICH MAY HAVE CAUSED THE GLENOID SPHERE DISLOCATION. "

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7233756 ↗
• InjuryNov 16, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  "(B)(6) 2017: INITIAL OPERATION FOR ROTATOR CUFF TEAR / (B)(6) 2017: SHOULDER DISLOCATION. TREATED MANUALLY. / (B)(6) 2017: SHOULDER DISLOCATION / (B)(6) 2017: REVISION FOR SHOULDER DISLOCATION. GLENOID SPHERE WAS SWITCHED TO A LARGER SIZE AND INSERT AND TRAY WERE REPLACED. THE SURGEON IS NOT SURE IF THE DEVICES HAVE CAUSED THE SHOULDER DISLOCATION."

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7036887 ↗
• InjuryDec 22, 2016Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY AT 14 MONTHS POST-OPERATIVE FOR INSTABILITY/DISLOCATION. STEM AND BASEPLATE REMAINED IMPLANTED FROM PREVIOUS SURGERY. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED FOR THIS PATIENT.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6197754 ↗
• InjuryJun 21, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT: "REVISION SURGERY FOR INSTABILITY/DISLOCATION". AT A CLINICAL VISIT ON (B)(6) 2013, THE PATIENT STATED THAT SHE FELT HER SHOULDER "DROP" WHILE DOING PASSIVE MOTION EXERCISE. THE PATIENT WAS DIAGNOSED WITH AN ANTERIOR DISLOCATION.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 5739943 ↗