AEQUALIS REVERSED FX / ADAPTER DWD860Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 03700386931499), received between Jun 12, 2017 and May 26, 2025 — classified as 14 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryMay 26, 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT.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) 2025. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2025 A PATIENT REQUIRED REVISION SURGERY DUE TO DISLOCATION/SUBLUXATION AND TRAUMATIC DISLOCATION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Joint Dislocation; Subluxation

  MAUDE report 22083319 ↗
• InjuryNov 7, 2024Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  PATIENT UNDERWENT REVERSE SHOULDER REPLACEMENT. POST-OP PERIOD WAS UNEVENTFUL UNTIL PATIENT'S PROSTHETIC SHOULDER JOINT DISLOCATED . JOINT WAS CLOSED REDUCED THAT EVENING, UNDER ANAESTHESIA. JOINT DISLOCATED AGAIN THE FOLLOWING DAY. DECISION MADE BY SURGEON TO PERFORM AN OPEN SURGICAL PROCEDURE, TO DETERMINE THE CAUSE OF THE INSTABILITY . DURING THIS PROCEDURE, THE GREATER TUBEROSITY, WHICH WAS REPAIRED DURING THE PRIMARY PROCEDURE, WAS FOUND TO BE RE-FRACTURED, AND HAD PULLED AWAY FROM THE PROXIMAL HUMERUS, WITH MILD BONE RESORPTION. SURGEON WAS UNABLE TO REPAIR / REDUCE IT. JOINT FOUND TO BE UNSTABLE, WITH CURRENT POLY INSERT. THIS POLY INSERT REMOVED, AND DISCARDED, AND AFTER MULTIPLE TRILLING WITH BOTH STANDARD AND RETENTIVE POLY INSERTS, A DEFINITIVE RETENTIVE INSERT WAS IMPLANTED - JOINT FOUND TO BE STABLE THROUGH A SATISFACTORY RANGE OF MOTION, WITH NO IMPINGEMENT.

  Patient problems: Bone Fracture(s); Joint Dislocation

  MAUDE report 20629055 ↗
• InjuryNov 7, 2024Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  PATIENT UNDERWENT REVERSE SHOULDER REPLACEMENT ON (B)(6) 2024, FOLLOWING A FALL. POST-OP PERIOD WAS UNEVENTFUL UNTIL PATIENT'S PROSTHETIC SHOULDER JOINT DISLOCATED. JOINT WAS CLOSED REDUCED THAT EVENING, UNDER ANAESTHESIA. JOINT DISLOCATED AGAIN THE FOLLOWING DAY. DECISION MADE BY SURGEON TO PERFORM AN OPEN SURGICAL PROCEDURE, TO DETERMINE THE CAUSE OF THE INSTABILITY. DURING THIS PROCEDURE, THE GREATER TUBEROSITY, WHICH WAS REPAIRED DURING THE PRIMARY PROCEDURE, WAS FOUND TO BE RE-FRACTURED, AND HAD PULLED AWAY FROM THE PROXIMAL HUMERUS, WITH MILD BONE RESORPTION. SURGEON WAS UNABLE TO REPAIR / REDUCE IT. JOINT FOUND TO BE UNSTABLE, WITH CURRENT POLY INSERT. THIS POLY INSERT REMOVED, AND DISCARDED, AND AFTER MULTIPLE TRAILING WITH BOTH STANDARD AND RETENTIVE POLY INSERTS, A DEFINITIVE RETENTIVE INSERT WAS IMPLANTED JOINT FOUND TO BE STABLE THROUGH A SATISFACTORY RANGE OF MOTION, WITH NO IMPINGEMENT.

  Patient problems: Bone Fracture(s); Joint Dislocation

  MAUDE report 20629043 ↗
• 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 20133388 ↗
• InjurySep 18, 2023Device 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 WITH THE TORNIER SHOULDER SYSTEM. THE REPORT DETAILS ANALYSIS PROVIDED FOR PROCEDURES PERFORMED BETWEEN APRIL 2012 ¿ MAY 2022. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2022 A PATIENT REQUIRED REVISION SURGERY DUE TO INSTABILITY/DISLOCATION/SUBLUXATION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Joint Dislocation; Joint Laxity; Subluxation

  MAUDE report 17769499 ↗
• InjuryJan 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFECTION WAS FOUND IN A PATIENT AFTER ARTIFICIAL SHOULDER JOINT SURGERY.

  Patient problems: Unspecified Infection

  MAUDE report 16202886 ↗
• InjurySep 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THERE WAS SUSPICION OF SUPERFICIAL INFECTION AT THE SURGICAL SITE OF THE ARTIFICIAL SHOULDER JOINT WAS CONSIDERED IN A PATIENT. AS A PRECAUTION, THE AFFECTED PART IS PLANNED TO BE CUT OPEN AND CONFIRMED AND AFTER CLEANING THE AFFECTED PART, REPLACEMENT OF THE INSERT MIGHT BE PERFORMED DEPENDING ON THE SITUATION OF THE INFECTION AT THAT TIME. THE SURGERY WAS PERFORMED AS SCHEDULED. THE SURGEON OPENED THE PART OF THE JOINT AND CONFIRMED THAT THERE WERE NO SYMPTOMS OF INFECTION IN OR AROUND THE JOINT PROSTHESIS. AS A PRECAUTION, THE INSERT IMPLANT WAS REPLACED. THIS INSERT WAS TO BE DISCARDED AT THE HOSPITAL DUE TO THE POSSIBILITY OF INFECTION. THERE WERE NO SYMPTOMS OF INFECTION IN THE SUBMUSCULAR LAYER, ONLY SOME CONTAMINATION IN THE SUBCUTANEOUS LAYER, WHICH WAS CLEANED AND THE TISSUE WAS SCRAPED OUT . THE SURGEON COMMENTED THAT IT WAS NOT A PROBLEM WITH THE IMPLANT SINCE THERE WAS NO PROBLEM IN THE JOINT OR AROUND THE PROSTHESIS, ONLY ON THE SURFACE.

  Patient problems: Skin Infection

  MAUDE report 12482518 ↗
• InjuryOct 15, 2019Component Missing; Component Missing

  DURING SURGERY IT WAS DETECTED FROM THE SALES REP WHO WAS PRESENT (B)(6) THAT THE INLAY DWD860 WAS MISSING. IT PROBABLY WAS NOT SENT TO FILL UP THE CONSIGNMENT THE LAST TIME THEY USED IT. A RETENTIVE INLAY WAS IMPLANTED INSTEAD. RISK FOR LIMITATION IN ROM AND NOTCHING. PATIENT NEEDED ADDITIONAL ANESTHESIA 45 MIN LONGER DUE TO SEARCH AND DECISION MAKING FOR ALTERNATIVE.

  Patient problems: Awareness During Anesthesia

  MAUDE report 9193495 ↗
• InjurySep 25, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2019, THE INITIAL SURGERY OF "AEQULIS REVERSE FRACTURE" AND "AEQULIS REVERSE" WAS PERFORMED ON THE LEFT SHOULDER. ON (B)(6) 2019, THE AFFECTED AREA WAS DISLOCATED WHEN PATIENT'S WEIGHT WAS APPLIED TO THE WALKER. THE SURGEON TRIED TO REDUCE IT THAT DAY, BUT IT DIDN'T WORK. LATER, WHEN THE SURGEON TOOK A CT (DATE IS UNKNOWN), IT WAS FOUND THAT A BONE FRAGMENT WAS CAUGHT BETWEEN THE INSERT AND THE SPHERE AND COULD NOT BE REDUCED. ON (B)(6) 2019, A REVISION SURGERY WAS PERFORMED. THE INSERT WAS REMOVED FOR REDUCTION.

  Patient problems: Joint Dislocation

  MAUDE report 9119500 ↗
• InjuryJul 5, 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 18 MONTHS AFTER PRIMARY SURGERY. PATIENT ID: (B)(6)".

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8765425 ↗
• InjuryJul 5, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  "IT WAS REPORTED THAT A PATIENT HAD A REVISION SURGERY DUE TO INSTABILITY/DISLOCATION ONE YEAR AFTER PRIMARY SURGERY. PATIENT ID: (B)(6)".

  Patient problems: Joint Dislocation

  MAUDE report 8765424 ↗
• InjuryDec 27, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  "IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY FOR INSTABILITY/DISLOCATION 5 DAYS POST-OPERATIVE. SUBJECT ID: (B)(6)."

  Patient problems: Joint Dislocation; Patient Problem/Medical Problem

  MAUDE report 8199145 ↗
• InjuryDec 19, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  "IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY DUE TO INSTABILITY/DISLOCATION 1 MONTH POST-OPERATIVE. SUBJECT ID: (B)(6)".

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8178388 ↗
• InjuryJun 12, 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 INSTABILITY/DISLOCATION. INSERT AND GLENOSPHERE WERE REPLACED, ALL OTHER COMPONENTS REMAINED THE SAME FROM PREVIOUS SURGERY.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6633020 ↗