FLEX SHOULDER SYSTEM DWF361BRecalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 03700386940507), received between Jul 7, 2016 and Oct 9, 2025 — classified as 32 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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, 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 33 reports, in the reporter's own words as published by the FDA.

• 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT.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 21875471 ↗
• 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 ↗
• InjuryAug 9, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD A POST-OPERATIVE COMPLICATION WITH INSTABILITY AND DISLOCATION OF THE DEVICE IN THE SHOULDER. THE PATIENT UNDERWENT A REVISION SURGERY WITH A COMPONENT CHANGE.

  Patient problems: Failure of Implant

  MAUDE report 12298372 ↗
• InjuryJul 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) 2020: ASCEND FLEX REVERSE SURGERY WAS PERFORMED. LATELY IN (B)(6) ,2020: SIGNS OF INFECTION WERE FOUND AFTER THE SURGERY. (B)(6) 2021: REVISION SURGERY WAS PERFORMED. ALL THE IMPLANTS WERE REMOVED, THE AFFECTED PART WAS CLEANED, THE SPACER MADE BY CEMENT WAS IMPLANTED, AND THE SURGERY WAS COMPLETED.

  Patient problems: Unspecified Infection

  MAUDE report 12142357 ↗
• InjuryJun 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS NECESSARY TO REMOVE THE REVERSE SHOULDER PROSTHESIS FROM THE PATIENT. AN (B)(6) WITH MILD-GRADE DIABETES THAT PRESENTED INFECTION WITH INDICATION FOR REMOVING THE PROSTHESIS. DURING THE SURGERY, ON (B)(6) 2021, THE PART OF THE HUMERUS IMPLANT WAS REMOVED WITHOUT PROBLEMS, FOLLOWED BY THE REMOVAL OF THE GLENOID IMPLANTS. AT THIS STAGE OF THE PROCEDURE, THE FOLLOWING EVENTS WERE REGISTERED: ) CONTAMINATION OF THE HEXAGONAL SCREWDRIVER, DWD167 AND REPLACEMENT WITH ANOTHER SCREWDRIVER OF THE SAME MODEL SUITABLE FOR FITTING; WITH THE SPARE SCREWDRIVER, THE SURGEON UNSUCCESSFULLY ATTEMPTED TO REMOVE THE GLENOID WITH NORMAL FORCE. SURGEON MADE ANOTHER ATTEMPT, NOW WITH THE GREATEST FORCE, CAUSING THE TIP OF THE SCREWDRIVER BREAK INSIDE THE ORIFICE OF THE GLENOSPHERE. THE TIP OF THE SCREWDRIVER REMAINS INSIDE THE PATIENT WITH THE ASSEMBLY OF THE GLENOSPHERE ON THE GLENOID BASE PLATE. THE DOCTOR FINISHED THE PROCEDURE WITHOUT REMOVING THE PROSTHESIS. NO, THERE WAS NO DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 11986601 ↗
• InjuryMay 21, 2021Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; 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: Failure of Implant; Joint Laxity

  MAUDE report 11866396 ↗
• InjuryMay 21, 2021Difficult to Insert; Difficult to Insert

  TOWARDS THE END OF THE OPERATION, AFTER THE STEM/TRAY ASSEMBLY HAS BEEN IMPLANTED INTO THE HUMERUS, WE OPENED THE REVERSED INSERT OF THE SIZE AND THICKNESS DETERMINED DURING THE TRIALING STEP. THE SURGEON PLACED EVEN PRESSURE ON THE INSERT TO INITIALLY SEAT THE INSERT INTO THE TRAY AND IT IMMEDIATELY ENTERED THE PLACE WITHOUT THE NEED OF USING THE IMPACTOR HANDLE AND INSERT TIP. THE SURGEON WAS ADVISED TO CHECK THAT THE CONNECTION BETWEEN THE TRAY AND INSERT WAS STRONG ENOUGH. USING ONLY HIS THUMB, VERY EASILY THE INSERT WAS PULLED OUT OF PLACE. IT WAS TRIED AGAIN TO MAKE AN IMPACTION BUT THE RESULT WAS SIMILAR. AT THE END OF THE OPERATION, A NEW 6 PLUS INSERT WAS IMPLANTED IN THE PATIENT'S BODY, WHICH IS THE SIZE THAT MATCHED THE PATIENT'S ANATOMY. THE SURGEON DID PUT IN A 9 PLUS EXPERIMENTAL IMPLANT JUST TO SEE WHICH SIZE WAS MORE APPROPRIATE, BUT AS MENTIONED CHOSE TO STICK WITH THE SMALLER INSERT. ADVERSE CONSEQUENCES WERE FRACTURE IN THE GLENOID, 2 REVISION SURGERIES SINCE REPORTED UNDER STRYKER REFERENCE PI 2693044.

  Patient problems: Bone Fracture(s)

  MAUDE report 11862764 ↗
• InjuryApr 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) 2020: ASCEND FLEX REVERSE SURGERY WAS PERFORMED. LATELY IN (B)(6) 2020: SIGNS OF INFECTION WERE FOUND AFTER THE SURGERY. (B)(6) 2021: REVISION SURGERY WAS PERFORMED. ALL THE IMPLANTS WERE REMOVED, THE AFFECTED PART WAS CLEANED, THE SPACER MADE BY CEMENT WAS IMPLANTED, AND THE SURGERY WAS COMPLETED.

  Patient problems: Unspecified Infection

  MAUDE report 11705807 ↗
• InjuryNov 10, 2020Unintended System Motion; Unintended Movement; Unintended System Motion; Unintended Movement

  ON (B)(6) 2019: AN INITIAL ASCEND FLEX REVERSE SURGERY WAS PERFORMED ON A PATIENT WITH A DYSFUNCTIONAL 1/3 OF THE DELTOID MUSCLE AND WAS COMPLETED WITHOUT PROBLEMS. THE POSITION OF THE TRAY USED AT THIS TIME WAS ALIGNED WITH "#6" IN THE LATERAL POSITION. (B)(6) 2020: THIS PATIENT PRESENTED FOR A PERIODIC CHECK UP. NO IMAGES WERE AVAILABLE, BUT X-RAYS DID NOT REVEAL ANY ABNORMALITIES. (B)(6) 2020: THIS PATIENT CAME TO THE HOSPITAL WITH COMPLAINTS OF PAIN. THE INSERT APPEARED TO BE INVERTED UPSIDE DOWN AND IT WAS DECIDED TO PERFORM THE REVISION SURGERY. (B)(6) 2020: THE REVISION SURGERY WAS PERFORMED. THE INSERT WAS FOUND REVERSED UPSIDE DOWN AND THE TRAY POSITION WAS FOUND SHIFTED IN "#12" INSTEAD OF "#6". HOWEVER, THE STEM AND THE TRAY WERE FIRMLY INTERLOCKED AND COULD NOT BE MOVED OR REMOVED AT ALL, SO THE STEM WASN'T REMOVED AND THE TRAY WAS LEFT IN THE BODY IN THE "NO. 12" POSITION, AND ONLY THE INSERT WITH ADDITIONAL THICKNESS WAS REPLACED IN THE USUAL ORIENTATION. THE SURGEON COMMENTED THAT HE DIDN'T KNOW WHY ONLY THE INSERT(OR ONLY THE TRAY) HAD ROTATED WITHOUT COMING OFF. SINCE THE TRAY WAS LEFT IN PLACE AS IT WAS THIS TIME, THIS PATIENT WILL NEED TO BE MONITORED FOR A WHILE

  Patient problems: Pain

  MAUDE report 10815494 ↗
• 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 (DWF521),AND THE INSERT INCREASED IN THICKNESS BY 6 MM AT A CONSTRAINED TYPE (DWF365B) .

  Patient problems: Joint Dislocation

  MAUDE report 10313214 ↗
• InjuryJul 9, 2020Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  AFTER THIS PATIENT HAD A ASCEND FLEX REVERSE SURGERY ON (B)(6) 2020, A DISLOCATION OCCURRED AT THE AFFECTED AREA. ON (B)(6) 2020, AN IMPLANT AT THE AFFECTED AREA WAS REPLACED AND THE SURGERY WAS FINISHED.

  Patient problems: Joint Dislocation; Joint Disorder

  MAUDE report 10249652 ↗
• InjuryFeb 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  "(B)(6) 2017: THE INITIAL SURGERY OF ""AEQUALIS REVERSE"" AND ""AEQUALIS ASCEND FLEX REVERSE"" WERE PERFORMED. (B)(6) 2018: THERE WAS A LEG FRACTURE. (B)(6) 2019: THE AFFECTED AREA GOT DISLOCATED AND THE REVISION SURGERY WAS SCHEDULED. (B)(6) 2020: THE REVISION SURGERY WAS PERFORMED. ALL THE IMPLANTS WERE REMOVED EXCEPT THE STEM, AND THE HEAD IMPLANT (DWF043) WAS NEWLY ATTACHED TO THE STEM. THE ILIAC BONE WAS IMPLANTED INTO THE GLENOID CAVITY, AND THE OPERATION WAS COMPLETED. THE SURGEON COMMENTED. ""AFTER THE FRACTURE OF THE LOWER LEG, WE RECOMMENDED TO MOVE ON A WHEELCHAIR THAT DID NOT APPLY A LOAD FROM BELOW, BUT THIS WAS PROBABLY DUE TO THE USE OF A WALKER AT THE REQUEST OF THE PATIENT. THERE WAS NO PROBLEM WITH THE IMPLANT.""

  Patient problems: Joint Dislocation

  MAUDE report 9705799 ↗
• InjuryDec 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  "(B)(6) 2018, THE INITIAL ASCEND FLEX REVERSE SURGERY WAS PERFORMED. (B)(6) 2019, A REVISION SURGERY WAS PERFORMED, DUE TO POSTOPERATIVE PAIN AND RESTRICTION OF HUMERAL ELEVATION AND ROTATION OCCURRED."THE SURGERY COMPLETED WITH A RESIZE OF THE GLENOID SPHERE, THE INSERT AND THE TRAY . ''I DON'T KNOW THE CAUSE, BUT IT'S NOT AN IMPLANT DEFECT. SINCE THE SELECTED SIZE IN THE FIRST CASE MAY NOT HAVE BEEN SUITABLE FOR THE PATIENT, WE TRIED REDUCING THE SPHERE DIAMETER.'' ,THE SURGEON COMMENTED. NO DELAY TO SURGERY.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 9519300 ↗
• InjuryDec 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  "(B)(6) 2017, THE INITIAL ASCEND FLEX REVERSE SURGERY WAS PERFORMED. (B)(6) 2019, POSTOPERATIVE PAIN AND RESTRICTION OF HUMERAL ELEVATION AND ROTATION OCCURRED. (B)(6) 2019, A REVISION SURGERY WAS PERFORMED. THE SURGERY COMPLETED WITH A RESIZE OF THE GLENOID SPHERE. COMMENTS FROM THE SURGEON: ''I DON'T KNOW THE CAUSE, BUT IT'S NOT AN IMPLANT DEFECT. SINCE THE SELECTED SIZE IN THE FIRST CASE MAY NOT HAVE BEEN SUITABLE FOR THE PATIENT, WE TRIED REDUCING THE SPHERE DIAMETER.''. NO DELAY IN SURGERY.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 9415266 ↗
• InjuryNov 8, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  "POST-OP CONTROL IN JULY WAS GOOD, IN SEPTEMBER PATIENT COMPLAINS PAIN AND INSTABILITY BECAUSE OF DISASSEMBLED GLENOSPHERE CAUSING POLYETHYLENE'S WEAR."

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 9297500 ↗
• InjuryOct 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  "(B)(6) 2019: A STAPHYLOCOCCAL INFECTION WAS FOUND IN THE AFFECTED AREA, AND A REVISION SURGERY WAS SCHEDULED FOR (B)(6) 2019."

  Patient problems: Unspecified Infection

  MAUDE report 9235631 ↗
• InjurySep 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  WHEN THE PATIENT WAS SEEN BY THE SURGEON FOR HIS 2 WEEK FOLLOW UP APPOINTMENT THE X-RAY SHOWED THAT THE ASSEMBLY SCREW HAD STARTED TO BACK OUT AND THE PROXIMAL BODY WAS DISASSOCIATING FROM THE DISTAL STEM FROM A DEVICE OF ANOTHER LEGAL MANUFACTURER. THEREFORE, ASCEND FLEX REVERSED TRAY AND REVERSED INSERT THAT WERE ASSEMBLED ONTO THE DEVICE FROM OTHER LEGAL MANUFACTURER WERE EXPLANTED AS A CONSEQUENCE OF THE EXPLANTATION OF THE DEVICE FROM THE OTHER LEGAL MANUFACTURER. THE EXPLANTATION OF THE AEQUALIS ASCEND FLEX COMPONENTS IS THE CONSEQUENCE OF THE EXPLANTATION OF THE DEVICE COMPONENTS OF THE OTHER LEGAL MANUFACTURER.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 9079531 ↗
• InjuryJul 15, 2019Malposition of Device; Malposition of Device

  AFTER THE SURGERY OF ASCEND FLEX RSA, BECAUSE THE FIXED POSITION OF THE SPHERE WAS NOT GOOD, SCAPULAR NOTCHING OCCURRED IN THE AFFECTED AREA. REVISION SURGERY PERFORMED ON (B)(6) 2019.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8788850 ↗
• InjuryApr 9, 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 AFTER PRIMARY SURGERY. SUBJECT ID: (B)(6)".

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8495324 ↗
• MalfunctionJan 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 8239833 ↗
• InjuryDec 12, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ON (B)(6) 2018, RSA OPERATION/ON (B)(6) 2018, DISLOCATION, DIFFICULT TO REDUCE/ON (B)(6) 2018, RSA REVISION SURGERY, CHANGE TO IMPLANTS OF LARGER SIZE GLENOID SPHERE AND CONSTRAINT INSERT. THE SURGEON COMMENTED "SINCE THE PATIENT WAS LEFT FOR SEVEN MONTHS FROM HIS DISLOCATION, THE CONTRACTURE OF THE SOFT PART WAS BAD AND IT WAS DIFFICULT TO USE A BIG SPHERE IMPLANT FROM THE INITIAL SURGERY. FEEL THAT EARLY OPERATION WAS NECESSARY FOR DISLOCATION CASES." REVISION SURGERY TO CHANGE TO IMPLANTS OF LARGER SIZE GLENOID SPHERE AND CONSTRAINT INSERT.

  Patient problems: Joint Dislocation

  MAUDE report 8155528 ↗
• InjuryJul 17, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  "IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY FOR LOOSENING/LYSIS AT 10 MONTHS POST-OPERATIVE. PATIENT ID: (B)(6)".

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7694200 ↗
• InjuryMar 6, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  "ON (B)(6) 2017: DEVICES WERE IMPLANTED. AROUND (B)(6) 2018: THE PATIENT'S SHOULDER HAD BEEN DISLOCATED. (B)(6) 2018: REVISION WAS DONE TO REPLACE INSERT. COMMENTS FROM SURGEON: THE PATIENT SUFFERS FROM DEMENTIA SO HOW HE DISLOCATED HIS SHOULDER WAS UNKNOWN. THE DEVICES HAD NOTHING TO DO WITH THE SHOULDER DISLOCATION."

  Patient problems: Dementia; Patient Problem/Medical Problem

  MAUDE report 7315816 ↗
• InjuryNov 22, 2017Mechanical Problem; Mechanical Problem

  "ASCEND FLEX REVERSED TRAY/LINER HAVE ROTATED FROM THEIR ORIGINAL POSITION. ON X-RAY AND CT THIS LOOKED TO BE THE LINER ROTATING INSIDE THE TRAY, HOWEVER IT WAS PROBABLY THE REVERSED TRAY ROTATING IN THE STEM. THE JOINT HAD BECOME UNSTABLE AND HAD TO BE REVISED. THIS REQUIRED IMPLANTATION OF A NEW REVERSE TRAY AND LINER. THE FLEX STEM WAS FOUND TO BE WELL FIXED, AND DID NOT REQUIRE REVISING. AT THE ORIGINAL SURGERY, THE REVERSED TRAY WAS ASSEMBLED TO THE FLEX STEM ON THE BACK TABLE. BOTH THE SURGEON AND THE SALES REP PRESENT ARE HAPPY ALL CORRECT SURGICAL STEPS AND TECHNIQUES WERE FOLLOWED."

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7052192 ↗