AEQUALIS REVERSED II DWD193Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 03700386935916), received between Sep 26, 2016 and Feb 16, 2026 — classified as 29 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

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

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT.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) 2023 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 24342837 ↗
• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT.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, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 24197593 ↗
• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT.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 JULY 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON 29-MAY-2024, A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 24197591 ↗
• InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, REVISION SURGERY WAS PERFORMED. 2 STAGE PROCEDURE AS LIKELY TO BE INFECTED. PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2022 WITH ASCEND FLEX AND REVERSE II IMPLANTS. ALL IMPLANTS WERE REMOVED AND PICTURED. A CEMENT SPACER WAS PLACED IN.

  Patient problems: Implant Pain; Osteolysis; Unspecified Infection

  MAUDE report 23871254 ↗
• InjuryAug 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 22735483 ↗
• InjuryJan 10, 2025Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  AS REPORTED: "SUBJECT: (B)(6) SHOUT - TORNIER SHOULDER OUTCOMES STUDY INSTABILITY ¿ DISLOCATION (ANTERIOR) DISLOCATED REVERSE."

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 21122594 ↗
• InjuryJan 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "SUBJECT: (B)(6). SHOUT - TORNIER SHOULDER OUTCOMES STUDY. CONSIDERABLE ONGOING LEFT SHOULDER PAIN AND INCREASING LEFT AXILLARY PAIN. NO INJURY. ON (B)(6) 2021, SUBJECT FIRST REPORTED CONSIDERABLE LEFT SHOULDER PAIN. X-RAYS AND PHYSICAL EXAM WERE NORMAL WITHOUT ANY EVIDENCE OF COMPLICATION. HE WAS INSTRUCTED TO RETURN IN 1 YEAR FOR ANNUAL FOLLOW UP. ON (B)(6) 2022, HE REPEATED THESE COMPLAINTS. YET AGAIN, X-RAYS DID NOT REVEAL EVIDENCE OF LOOSENING. SURGEON ATTEMPTED ASPIRATION TO SEND FOR CULTURE BUT WAS UNABLE TO OBTAIN ANY FLUID. SUBJECT WAS SENT FOR CBC, ESR, AND CRP LABS. SURGEON THOUGHT INFECTION WAS UNLIKELY BUT WANTED TO INVESTIGATE ALL POTENTIAL CAUSES FOR ONGOING PAIN. ON (B)(6) 2022, SUBJECT RETURNED WITH CONTINUED COMPLAINTS OF PAIN, ESPECIALLY AROUND THE PECTORALIS INSERTION AND TO A LESSER DEGREE IN THE BACK OF THE SHOULDER. HE COMPLAINED OF SOME MECHANICAL SYMPTOMS ESPECIALLY AT NIGHTTIME, WHEN HE IS POSITIONED IN BED, AND WITH MOTION. INFLAMMATORY LAB WORKUP WAS NEGATIVE. DR. (B)(6) SUGGESTED CT SCAN TO RULE OUT MECHANICAL COMPLICATIONS. ON (B)(6) 2022, SUBJECT RETURNED FOR CT REVIEW, WHICH DID NOT SHOW ANY MECHANICAL COMPLICATIONS. SURGEON STATED THAT

  Patient problems: Implant Pain; Loss of Range of Motion

  MAUDE report 21122535 ↗
• InjuryDec 30, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE STRYKER PROPHECY TEAM HAS RECEIVED A CT SCAN FOR THE UPCOMING REVISION SURGERY. THE REASON FOR THE REVISION IS UNSPECIFIED TRAUMA.

  Patient problems: Insufficient Information

  MAUDE report 21036827 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 (B)(6) 2012 ¿ (B)(6) 2022. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2019 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. REVISION PROCEDURE TYPE: DEBRIDEMENT AND IMPLANT RETENTION (DAIR).

  Patient problems: Unspecified Infection

  MAUDE report 20039444 ↗
• InjuryJul 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PATIENT UNDERWENT PRIMARY RIGHT SHOULDER REPLACEMENT, ON (B)(6) 2024, AT (B)(6) HOSPITAL, QLD. PATIENT UNDERWENT REVISION OF THIS SHOULDER JOINT, YESTERDAY (B)(6) 2024), AFTER A SHORT HISTORY OF PAIN, SWELLING, REDNESS OVER SURGICAL SITE. PT PRESENTED AT (B)(6) HOSPITAL LAST FRIDAY ((B)(6) 2024), WITH THESE SIGNS, AND FEELING GENERALLY UNWELL. CLINICAL DIAGNOSIS OF INFECTION, AS PER SURGEON'S COMMENTS YESTERDAY (SAME SURGEON). REVISION SURGERY YESTERDAY CARRIED OUT AT SUNSHINE COAST UNIVERSITY HOSPITAL. WOUND OPENED, MULTIPLE SPECIMENS TAKEN AS SEVERAL IMPLANTS WERE REMOVED AND REPLACED, AFTER COPIOUS LAVAGE / DEBRIDEMENT. HUMERAL TRAY AND POLY REPLACED. ASCEND FLEX STEM LEFT INSITU (APPEARED TO BE SOLIDLY FIXED). GLENOSPHERE REPLACED. 3 OF THE 4 BASEPLATE SCREWS REPLACED (4TH SCREW UNABLE TO BE REMOVED). BASEPLATE LEFT INSITU, VERY SLIGHT MOVEMENT OF BASEPLATE NOTED, AFTER THE 3 X SCREWS REMOVED, BUT SURGEON DECIDED TO LEAVE IT INSITU, AND AFTER THE NEW SCREWS WERE IMPLANTED, THE BASEPLATE APPEARED SOLIDLY FIXED."

  Patient problems: Erythema; Implant Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 19809163 ↗
• InjuryJul 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PT UNDERWENT PRIMARY RIGHT REVERSE SHOULDER REPLACEMENT, ON (B)(6) 2024. PT EXPERIENCED RECENT HISTORY OF PAIN, SWELLING, IN RIGHT PROSTHETIC SHOULDER JOINT. UNDERWENT REVISION ON (B)(6) 2024. MULTIPLE SPECIMENS TAKEN, TO DETERMINE IF INFECTION PRESENT - GLENOID COMPONENT, AND HUMERAL TRAY AND POLY REVISED. PT UNDERWENT A 2ND REVISION, ON (B)(6) 2024, DUE TO SIGNIFICANT SWELLING IN PROSTHETIC JOINT. WOUND OPENED, TO REVEAL LARGE COLLECTION OF HEMATOMA. NO OBVIOUS COLLECTION OF PUS. HUMERAL TRAY / POLY AGAIN REVISED, AS WELL AS THE GLENOSPHERE. MULTIPLE SPECIMENS AGAIN TAKEN. COPIOUS LAVAGE".

  Patient problems: Hematoma; Implant Pain; Swelling/ Edema

  MAUDE report 19716337 ↗
• InjuryApr 3, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A PATIENT REQUIRED REVISION SURGERY DUE TO WEAR ON THE GLENOID INFERIOR ALONG WITH THE PATIENT HAVING PAIN.

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 19036944 ↗
• InjuryOct 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS COMPLEX REGIONAL PAIN SYNDROME. PATIENT STARTED EXPERIENCING SYMPTOMS 2 WEEKS POST OPERATIVELY. PATIENT HAS BEEN GOING TO PHYSIO THERAPY TO MANAGE SYMPTOMS. EVENT IS ONGOING.

  Patient problems: Implant Pain

  MAUDE report 18012158 ↗
• InjuryAug 10, 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 (B)(6) 2022. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2018 A PATIENT REQUIRED REVISION SURGERY DUE TO DISLOCATION/SUBLUXATION DURING WHICH THE HUMERAL ARTICULATING BEARING WAS REVISED.

  Patient problems: Joint Dislocation

  MAUDE report 17505358 ↗
• InjuryNov 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A SHOULDER REPLACEMENT. THE PATIENT REPORTED OOZING OF THE WOUND POST-PROCEDURE. AN EXPLORATION SURGERY AND CULTURE REVEALED THE PRESENCE OF AN INFECTION. THE FIRST STAGE OF THE REVISION WAS COMPLETED WITH A WASH OUT.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 15815899 ↗
• InjuryOct 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT REVERSE SHOULDER REPLACEMENT ON (B)(6) 2019. PATIENT HAS HAD A LONG STANDING HISTORY OF WOUND INFECTION, WHICH HAS REQUIRED MULTIPLE RE-OPERATIONS FOR WOUND WASHOUT AND CHANGE OF POLY. SURGERY YESTERDAY ALSO RESULTED IN EXCHANGE OF HUMERAL POLY AND ALSO THE GLENOSPHERE ON THIS OCCASION, WITH COPIOUS LAVAGE. MULTIPLE TISSUE SPECIMENS TAKEN.

  Patient problems: Post Operative Wound Infection

  MAUDE report 15529476 ↗
• InjuryApr 14, 2022Migration; Migration

  IT WAS REPORTED THAT THE FLEX STEM WAS REVISED FOR LOOSENING DUE TO INFECTION. THE PATIENT WAS TREATED FOR INFECTION. THIS POTENTIALLY REDUCED THE FUNCTION AS THE STEM MOVED INTO THE VARUS.

  Patient problems: Unspecified Infection

  MAUDE report 14112298 ↗
• MalfunctionJun 16, 2021Difficult to Insert; Difficult to Insert

  THE SPHERE DID NOT ENGAGE WITH THE BASEPLATE WHEN THE SPHERE WAS IMPACTED ONTO THE BASEPLATE. BOTH COMPONENTS (THE SPHERE & BASEPLATE) WERE LEFT IN THE PATIENT. SURGEON TRIED SEVERAL TIMES TO ENGAGE THE SPHERE WITH THE BASEPLATE. THE DWD167 SCREWDRIVER WAS USED TO ASSEMBLE THE BASEPLATE AND GLENOSPHERE TOGETHER. THERE WAS A 3-5 MINUTE DELAY. THIS EVENT WAS A PRIMARY SURGERY.

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

  MAUDE report 12010990 ↗
• InjuryAug 7, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DISASSEMBLY BETWEEN THE BASEPLATE AND THE GLENOID SPHERE (TOTAL SHOULDER REVERSED PROSTHESIS, RIGHT SHOULDER). REVISION SURGERY AND IMPLANTATION OF A NEW GLENOSPHERE.

  Patient problems: Failure of Implant

  MAUDE report 10378512 ↗
• InjuryAug 13, 2019Difficult to Insert; Difficult to Insert

  THE GLENOSPHERES WOULD NOT ENGAGE WITH THE BASEPLATE. THE FIRST TWO SPHERES WERE REMOVED AND WILL BE SENT BACK. THE THIRD STILL DID NOT ENGAGE WITH BASEPLATE; HOWEVER, SURGEON LEFT IN PATIENT. UNKNOWN IMPACT TO PATIENT AT THIS TIME? ADDED AN EXTRA HOUR OF OR TIME TO SURGERY.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8887561 ↗
• InjuryAug 13, 2019Difficult to Insert; Difficult to Insert

  THE GLENOSPHERES WOULD NOT ENGAGE WITH THE BASEPLATE. THE FIRST TWO SPHERES WERE REMOVED AND WILL BE SENT BACK. THE THIRD STILL DID NOT ENGAGE WITH BASEPLATE; HOWEVER, SURGEON LEFT IN PATIENT. UNKNOWN IMPACT TO PATIENT AT THIS TIME? ADDED AN EXTRA HOUR OF OR TIME TO SURGERY.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8887559 ↗
• InjuryAug 13, 2019Difficult to Insert; Difficult to Insert

  THE GLENOSPHERES WOULD NOT ENGAGE WITH THE BASEPLATE. THE FIRST TWO SPHERES WERE REMOVED AND WILL BE SENT BACK. THE THIRD STILL DID NOT ENGAGE WITH BASEPLATE; HOWEVER, SURGEON LEFT IN PATIENT. UNKNOWN IMPACT TO PATIENT AT THIS TIME? ADDED AN EXTRA HOUR OF OR TIME TO SURGERY.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8887558 ↗
• InjuryMar 21, 2019Break; Break

  "IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY DUE TO GLENOID IMPLANT BREAKAGE 6 MONTHS POST-OPERATIVE. SUBJECT ID: (B)(6)."

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8439240 ↗
• InjuryMar 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  "IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY DUE TO PAIN 2 YEARS POST OPERATIVE. SUBJECT ID:(B)(6).

  Patient problems: Pain; Patient Problem/Medical Problem

  MAUDE report 8439239 ↗
• InjuryNov 6, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PATIENT HAD AN INSTABILITY/DISLOCATION (4 EPISODES OF ANTERIOR DISLOCATIONS OVER THE PAST YEAR); THE DISLOCATIONS SEEM TO HAPPEN WITH RAPID/DYNAMIC EXTERNAL ROTATION. PATIENT ID: (B)(6).

  Patient problems: Joint Dislocation

  MAUDE report 8041667 ↗