FLEX SHOULDER SYSTEM DWF510Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 03700386941054), received between Sep 26, 2016 and Apr 21, 2025 — classified as 23 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Inaccurate Information” (8 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 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionNov 10, 2021Inaccurate Information; Inaccurate Information

  THE SURGEON ASKED THE NURSE TO UNPACK A REVERSED TRAY ECC +1.5 (DWF510). HOWEVER IN THE PACKAGING WAS PRESENT A REVERSED TRAY ECC 0 (DWF500). A NEW IMPLANT HAVE BEEN OPENED WITH THE SAME REFERENCE BUT WITH A DIFFERENT LOT. NO MAJOR PROLONGATION OF THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12790736 ↗
• MalfunctionNov 9, 2021Inaccurate Information; Inaccurate Information

  WHEN OPENING THE PACKAGE WE IDENTIFIED THE PACKAGE AS BEING A AA FLEX HUMERAL TRAY (DWF510) . WHEN OPENING THE IMPLANT I IDENTIFIED THE IMPLANT BEING A DWF500. LUCKILY WE HAD AN OTHER IMPLANT SET ON SITE SO WE COULD USE A DWF510 FROM THAT KIT. IT DELAYED THE SURGERY OF 10 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12779141 ↗
• MalfunctionNov 9, 2021Inaccurate Information; Inaccurate Information

  THE IMPLANTS IN BOTH BOXES DO NOT CORRESPOND TO THE LABEL ON EACH PACKAGE/BOX. THE SURGEON PLANNED A ASCEND FLEX REVERSED TRAY LOW 1.5/+0MM IMPLANT AND GOT BY OPENING THE FIRST IMPLANT BOX AN ASCEND FLEX CENTERED TRAY INSTEAD. DUE TO THIS REJECTED PACK A SECOND IMPLANT (DWF510) WAS OPENED WITH INSIDE ANOTHER ASCEND FLEX CENTERED TRAY IMPLANT IDENTICAL TO THE ONE PACKED IN THE FIRST IMPLANT BOX. SURGERY WAS COMPLETED BY USING AND IMPLANTING AN ASCEND FLEX HIGH 3.5/+0MM REVERSED TRAY. IT DELAYED THE SURGERY OF MAX 10-15 MIN. NO ADDITIONAL ANESTHESIA WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12779139 ↗
• MalfunctionNov 9, 2021Inaccurate Information; Inaccurate Information

  WHEN OPENING THE PACKAGE WE IDENTIFIED THE PACKAGE AS BEING A AA FLEX HUMERAL TRAY (DWF510) . WHEN OPENING THE IMPLANT I IDENTIFIED THE IMPLANT BEING A DWF500. WE HAD NO OTHER OPTION, WE IMPLANTED THIS IMPLANT. IT DELAYED THE SURGERY OF10 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12779128 ↗
• MalfunctionNov 9, 2021Inaccurate Information; Inaccurate Information

  DISCREPANCY BETWEEN THE IMPLANT LABEL NOTED (ECCENTERED) ON THE PACKAGING AND THE IMPLANT INSIDE (CENTERED). OPENING OF ANOTHER IMPLANT. NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12779125 ↗
• MalfunctionNov 9, 2021Inaccurate Information; Inaccurate Information

  DISCREPANCY BETWEEN THE IMPLANT LABEL NOTED (ECCENTERED) ON THE PACKAGING AND THE IMPLANT INSIDE (CENTERED). WE HAD NO OTHER OPTION, WE IMPLANTED THIS IMPLANT. NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12779124 ↗
• MalfunctionOct 28, 2021Inaccurate Information; Inaccurate Information

  THE IMPLANT INSIDE THE BOX DOESN'T MATCH WITH THE REFERENCE NUMBERS ON THE PACKAGING (ASCEND FLEX REF DWF510 LOT 1197AW041). NO ADVERSE CONSEQUENCES FOR THE PATIENT. ANOTHER IMPLANT WITH THE SAME REFERENCE HAVE BEEN USED TO COMPLETE THE PROCEDURE SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12716246 ↗
• InjuryAug 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  POST-OPERATIVE COMPLICATION : INFECTION . RE-OPERATION WITHCOMPONENT CHANGE ON THE (B)(6) 2021 (NO INFORMATION REGARDING THE EXACT DEVICES REMOVED) IV ANTIBIOTICS, CEMENT ANTIBIOTIC SPACER ADDED.

  Patient problems: Unspecified Infection

  MAUDE report 12297926 ↗
• 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 12142353 ↗
• InjuryJun 10, 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) YEAR OLD 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 11979977 ↗
• MalfunctionJun 1, 2021Inaccurate Information; Inaccurate Information

  ABSENCE OF A DIAL TO REPRODUCE THE TEST IN ITS FINAL VERSION: IMPOSSIBLE TO IDENTIFY THE POSITIONING OF THE PLATFORM ON THE ROD, AND THE POSITIONING OF THE INSERT ON THE PLATFORM IMPLANT NOT CONFORM WITH THE NEEDED ONE. APPARENTLY THE PROBLEM HAS ALREADY BEEN REPORTED BECAUSE THE PLATFORM WOULD IN FACT BE A CENTERED 0 OF REF DWF 500 IN THE PACKAGING OF A DWF 510. NO SUBSTITUTE DEVICE SINCE ONLY ONE UNIT IN THE DEPOSIT ; APPROXIMATE AND RANDOM POSITIONING AT THE END. PROLONGATION OF FIFTEEN MINUTES OF THE SURGERY AND MANY HESITATIONS DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11916524 ↗
• 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 11705797 ↗
• 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. ON (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 WH

  Patient problems: Pain

  MAUDE report 10815493 ↗
• 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 10249654 ↗
• 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 10074002 ↗
• 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. SPRING, 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 9705790 ↗
• 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 9519307 ↗
• 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 9415256 ↗
• 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 9297501 ↗
• InjuryOct 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON "(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 9235630 ↗
• InjuryAug 19, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PATIENT HAD A REVISION SURGERY DUE TO DISLOCATION TWO MONTHS AFTER PRIMARY SURGERY. THE SUBJECT PICKED UP HER (B)(6) LB GRAND DAUGHTER AND THE IMPLANTED DISLOCATED. PATIENT ID: (B)(6).

  Patient problems: Joint Dislocation

  MAUDE report 8905898 ↗
• 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)(4)".

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8495322 ↗
• InjuryAug 20, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  "IT WAS REPORTED THAT A PATIENT UNDERWENT A CLOSED REDUCTION FOR INSTABILITY/DISLOCATION 7 MONTHS POST-OPERATIVE. PATIENT ID: (B)(6)".

  Patient problems: Joint Dislocation; Patient Problem/Medical Problem

  MAUDE report 7796942 ↗