AEQUALIS REVERSED II DWD181Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 03700386935831), received between Jul 27, 2016 and Jun 16, 2026 — classified as 18 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryJun 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ORIF OF A LEFT PROXIMAL HUMERAL HEAD FRACTURE FOLLOWING A FALL. THE PROCEDURE WAS REVISED TO A REVERSE SHOULDER ARTHROPLASTY DUE TO RADIOGRAPHIC EVIDENCE OF AVASCULAR NECROSIS OF THE HUMERAL HEAD. SHORTLY AFTER THE REVISION, THE PATIENT DEVELOPED A WOUND INFECTION WITH A CHRONIC DRAINING SINUS IN THE LEFT AXILLA. THE PATIENT REMAINED ON ORAL ANTIBIOTICS FOR APPROXIMATELY THREE YEARS. IN RECENT MONTHS, THE PATIENT REPORTED INCREASED PAIN AND DISCOMFORT IN THE LEFT SHOULDER. SINUS SWABS AND ASPIRATION CULTURES WERE POSITIVE FOR SERRATIA MARCESCENS AND STAPHYLOCOCCUS EPIDERMIDIS.

  Patient problems: Discomfort; Fluid Discharge; Pain; Post Operative Wound Infection

  MAUDE report 25526244 ↗
• InjuryApr 4, 2025Unstable; Unstable

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT.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) 2025. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2025 A PATIENT REQUIRED REVISION SURGERY DUE TO INSTABILITY, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Joint Laxity

  MAUDE report 21771639 ↗
• InjuryApr 9, 2024Unstable; Unstable

  AS REPORTED: "PRIMARY REVERSE SHOULDER ARTHROPLASTY, (B)(6) 2023. PATIENT COMPLAINED OF OCCASIONAL INSTABILITY, DISCOMFORT ON MOVEMENT, OF THIS SHOULDER JOINT, OVER MANY MONTHS. SURGEON CONCLUDED, DUE TO PATIENT UNDERGOING MULTIPLE OPERATIONS ON THIS SHOULDER, INCLUDING CUFF REPAIR, THAT THE PATIENT HAS A SOFT TISSUE ENVELOP INSTABILITY. DECISION MADE BY SURGEON TO INCREASE GLENOSPHERE SIZE, AND IMPLANT A MORE CONSTRAINED POLY LINER. THIS WAS PERFORMED, AND RANGE OF MOTION ON REDUCTION WAS ACCEPTABLE, AND JOINT FOUND TO BE STABLE. ALL OTHER PRIMARY IMPLANTS LEFT INSITU. HENCE, ONLY 3 X PROSTHESIS EXCHANGED - REVERSE TRAY, POLY INSERT AND GLENOSPHERE. SHOULDER JOINT STABLE AT CONCLUSION OF PROCEDURE."

  Patient problems: Discomfort; Joint Laxity; Loss of Range of Motion

  MAUDE report 19076079 ↗
• InjuryMar 7, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION OF REVERSE II GLENOID AND POLY LINER. THE GLENOID COMPONENT HAD BROKEN AWAY FROM THE GLENOID. THE GLENOSPHERE AND BASEPLATE HAD DISSOCIATED AND THERE WAS POLY WEAR. THE IMPLANTS WERE REMOVED AND REPLACED. A SCREW WAS USED TO REMOVE THE POLY LINER.

  Patient problems: Insufficient Information

  MAUDE report 18862182 ↗
• InjuryJan 17, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY AND STATIONARY TREATMENT DUE TO THE GLENOSPHERE DECOUPLING.

  Patient problems: Failure of Implant

  MAUDE report 16189209 ↗
• MalfunctionNov 22, 2022Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE SURGEON REQUESTED THE LATERALIZED GLENOID SPHERE +4MM THE MEDICAL DEVICE HAD THE FIXATION SCREW BLOCKED, PREVENTING ITS CORRECT IMPLANTATION IN THE 25MM SCREWED BASE PLATE. THE SURGEON TRIED TO LOOSEN THE SCREW SEVERAL TIMES WITHOUT SUCCESS. SURGEON DECIDED TO REQUEST A NEW GLENOSPHERE TO IMPLANT IT TO THE PATIENT. THE SURGEON DECIDED TO INSERT THE ECCENTRIC GLENOID SPHERE +2MM. THE SURGERY ENDS WITHOUT SERIOUS EVENTS AND THE PATIENT DOES NOT PRESENT ANY PROBLEM OR SERIOUS REPERCUSSION. DUE TO THIS SITUATION, THE SURGEON DID NOT ALLOW THE DISORTHO SURGICAL ASSISTANT TO CHARGE THE CENTERED GLENOID SPHERE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15849148 ↗
• InjuryApr 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD ULNAR NERVE TUNNEL SYNDROME AND SEVERE PAIN POST-OPERATIVE.

  Patient problems: Nerve Damage; Pain

  MAUDE report 14197158 ↗
• InjuryFeb 25, 2022Loosening of Implant Not Related to Bone-Ingrowth; Migration; 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 13607025 ↗
• InjuryApr 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF AN ASCEND FLEX/ REVERSED FOR A PROBLEM ON THE GLENOID SIDE, ON (B)(6) 2021. PATIENT STARTED TO BE PAINFUL IN (B)(6) 2020 (I.E. ROUGHLY 6 YEARS AFTER INITIAL SURGERY IN NOV 2014). LOSS OF ROM WAS ALSO NOTED. THE X-RAYS SHOWED 3 BROKEN PERIPHERAL SCREWS.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 11705799 ↗
• InjuryOct 1, 2020Device Difficult to Setup or Prepare; Mechanical Jam; Device Difficult to Setup or Prepare; Mechanical Jam

  DURING THE SURGICAL PROCEDURE WHEN THE DOCTOR REQUESTED THE 10° TILTED SPHERE (REFERENCE DWD181, SERIAL NUMBER (B)(4)), THE MEDICAL DEVICE HAD THE SCREW BLOCKED, PREVENTING ITS PROPER IMPLANTATION TO THE THREADED POST BASEPLATE (REFERENCE DWD725, SERIAL NUMBER (B)(4)). THE SURGEON TRIED TO RELEASE THE SCREW SEVERAL TIMES WITHOUT SUCCESS. THE DOCTOR SANCHEZ DECIDES APPLY FOR THE ECCENTRIC GLENOID SPHERE (REFERENCE DWD182, SERIAL NUMBER (B)(4)) TO IMPLANT IT THE PATIENT BUT HAD THE SAME PROBLEM, THE MEDICAL DEVICE HAD THE SCREW BLOCKED. THE SURGEON DECIDES TO INSERT THE CENTERED GLENOID SPHERE, (REFERENCE DWD180, SERIAL NUMBER (B)(4)). THE SURGERY ENDS WITHOUT SERIOUS EVENTS AND THE PATIENT DOES NOT HAVE ANY PROBLEM OR SERIOUS IMPACT. THIS EVENT IMPLIED THAT THE ANESTHESIA TIME WAS EXTEND FOR A PERIOD OF 40 MINUTES.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10612217 ↗
• InjuryMar 12, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT DESCRIBED CLICKING, X-RAY SHOWED GLENOSPHERE DISSOCIATED FROM BASEPLATE, ONE YEAR POST-OPERATIVE.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 9823321 ↗
• InjuryFeb 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  GLENOID SPHERE WAS SEATED AND LOCKED PROPERLY DURING SURGERY ON (B)(6) 2020, BUT DURING A FOLLOW UP VISIT TO DR (B)(6) ON (B)(6) 2020 FOUND TO BE DISLOCATED WITH A SPHERE THAT CAME LOOSE AND POPPED OFF THE GLENOID BASEPLATE. THE SAME SPHERE WAS RE-SEATED AND LOCKED ONTO THE BASEPLATE DURING SURGERY ON (B)(6), BUT FOUND TO BE LOOSE AGAIN. ANOTHER COMPONENT WAS OPENED AND USED. A BACK UP GLENOID SPHERE COMPONENT WAS OPENED AND INSERTED. REVISION, DEVICE NOT EXPLANTED. AN EXTRA SURGICAL PROCEDURE WAS SCHEDULED TO REVISE THE GLENOID.

  Patient problems: Joint Dislocation

  MAUDE report 9744278 ↗
• InjuryJan 7, 2020Material Fragmentation; Inadequacy of Device Shape and/or Size; Material Fragmentation; Inadequacy of Device Shape and/or Size

  TIP OF THE SCREWDRIVER GRIPPED IN THE GLENOSPHERE. DELAY HAS BEEN 30 MINUTES. IN ONE OF THE GLENOSPHERES THE TIP OF THE SCREWDRIVER REMAINED. IT BROKE WHILE TRYING TO UNSCREW IT ON THE TABLE, WE HAD A SECOND SCREWDRIVER TIP IN THE INSTRUMENTS. INADEQUATE SIZE IMPLANT TO COMPLETE THE CASE. PATIENT ENDED WITH 42 HEAD SIZE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9558293 ↗
• MalfunctionDec 4, 2019Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  CENTER LOCKING SCREW OF SPHERES WERE LOCKED IN SPHERES. COULD NOT RELEASE THE SCREW IN ANY DIRECTION. 60 MINUTES DELAYED.

  Patient problems: Failure of Implant

  MAUDE report 9410136 ↗
• 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 9297503 ↗
• 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 8315277 ↗
• 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 8159457 ↗
• MalfunctionDec 5, 2018Difficult to Insert; Device Difficult to Setup or Prepare; Use of Device Problem; Difficult to Insert; Device Difficult to Setup or Prepare; Use of Device Problem

  DR (B)(6) PUT A BASEPLATE DWD172 WITHOUT ANY ISSUE AND ADDED THE SCREWS. WHILE TRYING TO PUT THE GLENOID SPHERE, IT WAS IMPOSSIBLE TO SCREW. AFTER CLEANING OF THE GLENOID 4 TIMES IN A ROW, THERE WAS NO IMPROVEMENT. THE 4TH TIME, WHEN THE SPHERE DWD180 WAS REMOVED, IT FELL. THE SURGEON PROPOSED THE USE OF A DWD181 AND FACED THE SAME ISSUE. HE TRIED AGAIN AND WHILE SCREWING, FELT THAT THE SCREW THREAD WAS APPARENTLY FUNCTIONING CORRECTLY AND AT THE LAST MOMENT, THERE WAS A SUDDEN JUMP. THE SURGEON CONCLUDED THAT THE SCREW THREAD WAS DEFECTIVE. THE SURGERY WAS COMPLETED WITH A 40 MINUTES DELAY AND ADDITIONAL ANESTHESIA. THE 25 MM BASEPLATE WAS REMOVED AND THE SURGEON USED A 29 MM BASEPLATE INSTEAD.

  Patient problems: Failure of Implant; No Information

  MAUDE report 8132784 ↗
• InjuryDec 11, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY DUE TO LOOSENING OF THE GLENOID COMPONENT. REVERSE SHOULDER ARTHROPLASTY CONVERTED TO HUMERAL HEMIARTHROPLASTY. STEM REMAINED THE SAME IMPLANTED FROM THEIR PRIMARY SURGERY. (B)(6).

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7104518 ↗
• InjuryAug 1, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE SURGERY WHEN THE SURGEON REQUESTED THE GLENOID SPHERE FOR IMPLANTATION, REFERENCE DWD182 SERIAL NUMBER (B)(4), THE MEDICAL DEVICE HAD THE SCREW BLOCKED, PREVENTING ITS PROPER IMPLEMENTATION TO THE BASE PLATE. THE SURGEON TRIED SEVERAL TIMES TO RELEASE THE SCREW UNTIL THE 3.5 MM HEXAGONAL SCREWDRIVER TIP BROKE. THE DOCTOR TRIED TO IMPLANT OTHER SPHERE DWD181 SERIAL NUMBER (B)(4) WITH A NEW 3.5 MM HEXAGONAL SCREWDRIVER BUT HAD THE SAME PROBLEM AND THE 3.5 MM HEXAGONAL SCREWDRIVER TIP BROKE AGAIN.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6757595 ↗
• InjuryJul 27, 2016Disassembly; Disassembly

  DURING A FOLLOW-UP X-RAYS IT WAS REPORTED THAT A GLENOSPHERE DISASSOCIATED FROM BASEPLATE. NO INTERVENTION LISTED AT THIS TIME.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 5825203 ↗