FLEX SHOULDER SYSTEM DWF520Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 03700386941078), received between Aug 16, 2016 and Dec 29, 2025 — classified as 29 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (9 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT.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 ↗
• 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT.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 ↗
• 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 FOR INFECTION. POLY INSERT AND TRAY WERE REMOVED, STEM LEFT, GLENOSPHERE WAS REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 13606828 ↗
• InjuryFeb 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY FOR INFECTION AT 3 MONTHS POST-OP. POLY INSERT, TRAY AND GLENOSPHERE WERE REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 13606696 ↗
• InjuryDec 20, 2021Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  IT WAS REPORTED THAT PATIENT (B)(6) UNDERWENT A REVISION SURGERY SEVEN YEARS AFTER PRIMARY STUDY SURGERY DUE TO INSTABILITY/DISLOCATION. "THERE WAS ALSO LOOSENING OF THE PROSTHESIS, ROTATOR CUFF INSUFFICIENCY, POLY WEAR, AND THE PATIENT HAD PAIN." "AEQUALIS REVERSED II GLENOSPHERE WAS REMOVED, AS WELL AS AEQUALIS ASCEND FLEX REVERSED INSERT AND TRAY. INSERT WAS REPLACED TO 42+9A; THE TRAY WAS REPLACED TO A HIGH+0." THE AEQUALIS ASCEND FLEX STEM AND THE AEQUALIS REVERSED II BASEPLATE WERE RETAINED FROM PREVIOUS SURGERY.

  Patient problems: Implant Pain; Muscle Weakness/Atrophy

  MAUDE report 13049290 ↗
• InjuryNov 24, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT UNDERWENT A FIRST REVISION SURGERY DUE TO INSTABILITY/DISLOCATION ON (B)(6) 2017. THE ASSOCIATED ADVERSE EVENT DATED (B)(6) 2017 DESCRIBES A DISLOCATED REVERSE WITH A DEFINITE RELATEDNESS TO THE SURGICAL PROCEDURE AND NO RELATEDNESS TO THE STUDY DEVICE.

  Patient problems: Failure of Implant

  MAUDE report 12867144 ↗
• InjurySep 16, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO LOOSENING/LYSIS OF THE IMPLANT.

  Patient problems: Failure of Implant; Osteolysis

  MAUDE report 12484231 ↗
• InjuryJun 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2016. ON (B)(6) 2017, REVISION SURGERY FOR INFECTION WAS PERFORMED (CONVERSION OF THE REVERSE SHOULDER ARTHROPLASTY (RSA) TO HRP. ALL TORNIER COMPONENTS WERE REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 11942228 ↗
• InjuryMay 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED ON (B)(6) 2021 DUE TO INSTABILITY POST REVERSE TOTAL SHOULDER REPLACEMENT (TORNIER THREADED POST BASEPLATE, SCREWS, GLENOSPHERE, TRAY AND INSERT REMOVED BY THE SURGEON IN DURANGO CO). TORNIER FLEX PTC 6B LONG STEM WAS REPORTED WELL FIXED BY THE SURGEON, SO RETAINED IN PATIENT. THE PATIENT WAS COMPLIANT TO MOBILIZATION INSTRUCTIONS OF THE SURGEON BUT NOT THE LONG TERM WEIGHT RESTRICTIONS. THE SURGEON DID NOT WANT TO PROVIDE THE CT SCANS. THE PATIENT WAS PULLING HOSES 9 MONTHS POST OP AND FELT A "POP" THAT WAS PRESUMABLY A DISLOCATION HE STATES, MULTIPLE SELF REPORTED DISLOCATIONS, NONE DOCUMENTED UNTIL LATE WINTER EARLY OF 2021. THE SURGEON WANTS TO MAKE SURE IT¿S CLEARLY UNDERSTOOD THAT HE HAS NO COMPLAINT AGAINST OUR PRODUCTS, JUST REPORTING AS ASKED OF A REVISION TOTAL SHOULDER. REVERSED INSERT WERE IMPLANTED.

  Patient problems: Joint Laxity

  MAUDE report 11866460 ↗
• InjuryMar 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD MULTIPLE DISLOCATIONS OF HER STUDY SHOULDER (LEFT) 17 MONTHS POST-OPERATIVE, ESPECIALLY 4 TIMES DURING THE WEEK BEFORE LAST VISIT ((B)(6) 2021). "THE PATIENT WAS ABLE TO REDUCE HER SHOULDER AFTER EACH INCIDENT. DR (B)(6) RECOMMENDS A REVISION SURGERY TO INCREASE THE TRAY AND/OR INSERT THICKNESS."PATIENT ID: (B)(6).

  Patient problems: Joint Dislocation

  MAUDE report 11410193 ↗
• 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)(4).

  Patient problems: Joint Dislocation

  MAUDE report 11265243 ↗
• InjuryDec 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AEQUALIS ASCEND FLEX REVERSED TRAY WAS EXTRACTED DUE TO A CHRONIC INFECTION. AN ANTIBIOTIC CEMENT SPACER WAS INSERTED UNTIL A LATER DATE.

  Patient problems: Unspecified Infection

  MAUDE report 11094711 ↗
• InjurySep 17, 2020Positioning Failure; Positioning Failure

  DWF391B REVERSE INSERT DID NOT ENGAGE INTO THE REVERSE TRAY WHEN PUTTING TOGETHER THE DEFINITIVE IMPLANTS. SURGEON TRIED MULTIPLE TIMES TO ENGAGE THE POLY ONTO THE TRAY BUT THERE WAS ALWAYS A GAP BETWEEN POLY AND TRAY. BOTH TRAY AND POLY WERE DISCARDED AND NEW IMPLANTS USED AS SURGEON WAS NOT SURE WHAT COMPONENT T WAS CAUSING THE ISSUE.

  Patient problems: Failure of Implant

  MAUDE report 10545885 ↗
• InjuryJul 23, 2020Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020: THE FIRST SURGERY FOR ASCEND FLEX REVERSE WAS PERFORMED. DATE UNKNOWN: AFTER THE SURGERY, A POSTERIOR UPWARD DISLOCATION OCCURRED. IT WAS POSSIBLE TO PERFORM A MANUAL REDUCTION, BUT DUE TO THE IMMEDIATE POSTOPERATIVE DISLOCATION, IT WAS DECIDED TO PERFORM THE SURGERY. ON (B)(6), 2020: THE REVISION SURGERY WAS PERFORMED. ONLY THE TRAY AND THE INSERT WERE REPLACED AND THE SURGERY WAS COMPLETED. THE TRAY INCREASED IN THICKNESS BY 6 MM ((B)(4)),AND THE INSERT INCREASED IN THICKNESS BY 6 MM AT A CONSTRAINED TYPE ((B)(4)) .

  Patient problems: Joint Dislocation

  MAUDE report 10313208 ↗
• 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 9882235 ↗
• InjuryNov 8, 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 4 YEARS AFTER PRIMARY SURGERY. PATIENT ID: (B)(6)".

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 9297508 ↗
• InjurySep 17, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT UNDERWENT INITIAL RSA ON (B)(6) 2017. THE IMPLANTS USED WERE ASCEND FLEX STD PTC HUMERAL STEM (DWF603B), REVERSE INSERT (DWF362B), REVERSE TRAY (DWF520), REVERSED II DIA. 25 PRESS FIT POST BASE PLATE (DWD170) AND REV. II GLENOID SPHERE DIA. 25 BASE PLATE (DWD180). ON (B)(6) 2017, A DISLOCATION OCCURED AND REVISION SURGERY WAS PERFORMED. DURING THIS SURGERY, TRAY (DWF520), INSERT (DWF391B), AND SPHERE (DWH905) WERE NEWLY USED. IN 2019 (NO DATE), DISLOCATION OCCURRED AGAIN AND MANUAL REDUCTION WAS PERFORMED, BUT A REVISION SURGERY WAS TO BE PERFORMED AGAIN. ON (B)(6) 2019, REVISION SURGERY WAS PERFORMED: ASCEND FLEX: LONG PTC HUMERAL STEM 4B 132.5° 104MM (DWF614B), REVERSED INSERT 42 MM (+) 9 B-12.5 (DWF425B), REV. II GLENOID SPHERE DIA. 25 BASEPLATE DIA. 42 MM 10 TILTED SPHERE (DWD184), ASCEND FLEX REVERSED TRAY (+) 0 1.5 MM (DWF510) WERE NEWLY REPLACED.

  Patient problems: Joint Dislocation

  MAUDE report 9079533 ↗
• InjuryJun 20, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  "IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY DUE TO ANTEROSUPERIOR ESCAPE, 1 YEAR AFTER PRIMARY SURGERY. SUBJECT ID: (B)(6)".

  Patient problems: Joint Dislocation; Patient Problem/Medical Problem

  MAUDE report 8716315 ↗
• InjuryJan 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 3 YEARS POST-OPERATIVE, WITH ONE BROKEN MULTIDIRECTIONAL SCREW. SUBJECT ID: (B)(6).

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8239737 ↗
• InjuryNov 6, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PATIENT HAD AN INSTABILITY/DISLOCATION (4 EPISODES OF ANTERIOR DISLOCATIONS OVER THE PAST YEAR) ; THE DISLOCATIONS SEEM TO HAPPEN WITH RAPID/DYNAMIC EXTERNAL ROTATION. PATIENT ID: (B)(4).

  Patient problems: Joint Dislocation

  MAUDE report 8041675 ↗
• InjuryNov 29, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  WE DID A PRIMARY REVERSE ON A PATIENT IN (B)(6) ON (B)(6) WITH DR (B)(6). PATIENT HAD A HISTORY OF FALLS AND WAS GENERALLY NON COMPLIANT. PT DISLOCATED AND WE CHANGED THE 42X6MM POLY TO A 42X9MM POLY ON (B)(6). PT DISLOCATED AGAIN AND WE REVISED THIS PT AGAIN ON (B)(6). THIS TIME WHEN THE DOC OPENED THE PATIENT, THE REVERSE TRAY AND THE POLY WERE DISASSOCIATED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7066491 ↗
• InjuryNov 17, 2017Missing Value Reason; Missing Value Reason

  PARTIAL RESORPTION OF THE GREATER TUBEROSITY (VERY MODERATE, BETWEEN THE TRAY AND THE STEM). PATIENT ID: (B)(6).

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7040381 ↗
• 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 7036891 ↗
• InjuryNov 9, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  "IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY DUE TO INSTABILITY/ DISLOCATION. HUMERAL COMPONENTS AND GLENOID SPHERE WERE CHANGED, + SAMPLE AND WASHING." PATIENT ID: (B)(6).

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7013156 ↗