AEQUALIS REVERSED II DWD170Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 03700386935947), received between Mar 24, 2017 and Sep 4, 2024 — classified as 15 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

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

• InjurySep 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "THE DETAILS ARE UNKNOWN, THE PRIMARY SURGERY FOR ARTIFICIAL SHOULDER JOINT REPLACEMENT WAS PERFORMED AT ANOTHER HOSPITAL ABOUT 6 YEARS AGO. ABOUT 2 YEARS AGO, THE PERIPROSTHETIC SHOULDER JOINT FRACTURE AROUND THE ARTIFICIAL SHOULDER JOINT WAS OCCURRED AND PERFORMED THE PLATING SURGERY. AFTER PLATING SURGERY, THE SURGERY FOR REMOVING THE PLATE AND SCREWS WAS PERFORMED DUE TO INFECTION. ON (B)(6) 2024, THE SURGERY FOR REMOVING ARTIFICIAL SHOULDER JOINT WAS PERFORMED DUE TO THE INFECTION AROUND THE STEM".

  Patient problems: Unspecified Infection

  MAUDE report 20133386 ↗
• InjuryOct 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN A LAWSUIT THAT THE PATIENT REPORTED HAVING REFRACTORY PAIN AND DYSFUNCTION OF THE SHOULDER WHICH WAS REFRACTORY TO CONSERVATIVE MEASURES. PREOPERATIVE IMAGING WAS SUGGESTIVE OF LOOSENING OF THE HUMERAL COMPONENT, SPECIFICALLY AT THE JUNCTION OF THE PROXIMAL HUMERAL BODY TO THE HUMERAL STEM AT THE ASSEMBLY SCREW JUNCTION.

  Patient problems: Implant Pain

  MAUDE report 17906599 ↗
• InjuryFeb 25, 2022Material Fragmentation; Loosening of Implant Not Related to Bone-Ingrowth; Migration; Material Fragmentation; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  "IT WAS REPORTED, DURING 5YFU, THAT A PATIENT HAD A GLENOID LOOSENING (XRAYS SHOW A BROKEN SCREW AND APPARENT UPWARD MIGRATION OF GLENOSPHERE). PATIENT ID: (B)(6)".

  Patient problems: Failure of Implant

  MAUDE report 13607017 ↗
• InjuryFeb 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT (B)(6) UNDERWENT A REVISION SURGERY DUE TO DEEP INFECTION. REMOVAL OF AEQUALIS ASCEND FLEX HUMERAL COMPONENTS (STEM, TRAY AND INSERT) AND AEQUALIS REVERSED GLENOID COMPONENTS (BASEPLATE AND GLENOSPHERE). PRIOR SURGERIES ON STUDY SHOULDER: ROTATOR CUFF REPAIR, ACROMIOPLASTY, DISTAL CLAVICLE RESECTION.

  Patient problems: Unspecified Infection

  MAUDE report 13497193 ↗
• InjurySep 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, THIS PATIENT HAD AN INITIAL SURGERY OF AEQUALIS REVERSE AT (B)(6) ORTHOPEDICS HOSPITAL. ON (B)(6) 2020, AN INFECTION WAS FOUND AT THE AFFECTED PART AT THE SAME HOSPITAL. ON (B)(6) 2020, A REVISION SURGERY WAS PERFORMED AT (B)(6) MEDICAL CENTER. AFTER REMOVING ALL THE IMPLANTS,THE MOLD CEMENT WHICH INCLUDES ANTIBIOTICS WAS IMPLANTED TO THE HUMERAL AND THE SURGERY WAS COMPLETED. AFTER SEVERAL MONTHS OF FOLLOW-UP, ANOTHER REVISION SURGERY MIGHT BE PERFORMED FOR NEW IMPLANTS DEPENDING ON THE RECOVERY SITUATION.

  Patient problems: Unspecified Infection

  MAUDE report 10475818 ↗
• 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 10249653 ↗
• 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 9705802 ↗
• InjuryFeb 7, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE INITIAL SURGERY ON THE LEFT SHOULDER WAS HELD ON (B)(6) 2018. THE BASE PLATE WAS DISLOCATED ON (B)(6) 2019, AND REVISION SURGERY WAS PERFORMED ON (B)(6) 2019. ON (B)(6), THE FRACTURE OF THE GLENOID CAVITY DUE TO DISLOCATION WAS CONFIRMED DURING REVISION SURGERY. THE BONE GRAFT WAS DONE IN THE GLENOID CAVITY, AND THE HUMERUS SIDE WAS TREATED WITH A CEMENT TYPE CONTAINING ANTIBIOTICS. AFTER ABOUT SIX MONTHS FOLLOW-UP, THE SURGEON WILL DECIDE WHETHER TO REPLACE THE BASE PLATE WHILE WATCHING THE RECOVERY STATUS OF THE BONE.

  Patient problems: Joint Dislocation

  MAUDE report 8315276 ↗
• InjuryDec 13, 2018Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  "IT WAS REPORTED THAT A PATIENT HAD A GLENOID COMPONENTS' LOOSENING 9 MONTHS POST-OPERATIVE. PATIENT ID: (B)(6)".

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8159456 ↗
• InjuryJul 12, 2018Mechanical Problem; Device Dislodged or Dislocated; Mechanical Problem; Device Dislodged or Dislocated

  "IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY FOR DISSOCIATION 1 YEAR POST-OPERATIVE. PATIENT ID : (B)(6)".

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7681372 ↗
• InjuryMay 18, 2018Adverse 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

  (B)(6) 2015: INITIAL RSA SURGERY. / (B)(6) 2015: OBSERVED BONE RESORPTION BY NOTCHING IN X-RAY AT 6 MONTHS CHECK. / (B)(6) 2016: SEEMS THE BONE RESORPTION HAS STOPPED. / (B)(6) 2018: GLENOID COMPONENT ELIMINATION. BONE GRAFTING.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7525297 ↗
• 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 7233747 ↗
• InjuryNov 21, 2017Disassembly; Disassembly

  THE SPHERE AND BASEPLATE HAD BECOME LOOSENED AND SPHERE AND INSERT WERE REPLACED WITH NEW ONES. THE SURGEON SAID THAT THE SCREWS IN THE SPHERE WERE NOT TIGHTENED ENOUGH AT THE INITIAL OPERATION.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7048097 ↗
• InjuryMay 10, 2017Adverse Event Without Identified Device or Use Problem; Missing Value Reason; Adverse Event Without Identified Device or Use Problem; Missing Value Reason

  SINCE THE PATIENT HAD INFECTION, ALL IMPLANTS WERE REMOVED AND THE INSERTION SITE WAS FILLED WITH A CEMENT CONTAINING ANTIBIOTICS. THE PATIENT RECEIVED CONSERVATIVE TREATMENT.

  Patient problems: Unspecified Infection

  MAUDE report 6556614 ↗
• InjuryMar 24, 2017Adverse Event Without Identified Device or Use Problem; Missing Value Reason; Adverse Event Without Identified Device or Use Problem; Missing Value Reason

  THE PATIENT COMPLAINED PAIN 16 MONTHS AFTER THE OPERATION AND THE PATIENT WAS TREATED WITH INTRA-ARTICULAR CLEANSING AND ANTIBIOTICS FOR 6 MONTHS BUT SINCE THERE WAS NO IMPROVEMENT, ALL THE DEVICES WERE REMOVED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 6432122 ↗