AEQUALIS REVERSED DWB993Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 03700386916540), received between May 10, 2017 and Sep 18, 2026 — classified as 29 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (7 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 29 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 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  The manufacturer received a report from the National Joint Registry that contains unpublished collected data on the usage and the outcomes of the shoulder joint replacement.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) 2026.During the review of the report, it was identified that on (b)(6) 2026 a patient required revision surgery due to infection, which was not previously reported to the manufacturer.

  Patient problems: Unspecified Infection

  MAUDE report 50819879 ↗
• InjuryMay 29, 2026Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  It was reported that the patient underwent a right primary reverse shoulder arthroplasty. At approximately two-year follow-up, the patient presented with shoulder pain and reduced range of motion. The surgeon noted reported non-compliance with postoperative rehabilitation and a history of potential trauma while climbing in and out of a truck.During revision surgery, the glenoid component was found to be loose and dissociated from the glenoid bone and was easily removed. The humeral component remained well fixed and was retained. The polyethylene insert exhibited eccentric wear, and grey synovial tissue was observed and excised. Copious lavage was performed.New glenoid components were implanted with the addition of synthetic bone graft. A new humeral polyethylene insert was placed. The shoulder was reduced and found to be stable through range of motion.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 25330998 ↗
• InjuryJan 5, 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) 2025. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2025 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 23958148 ↗
• InjuryDec 3, 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 OCT. 2025. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2025 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 23705896 ↗
• InjuryJul 9, 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) 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2025 A PATIENT REQUIRED REVISION SURGERY DUE TO PERIPROSTHETIC FRACTURE, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Bone Fracture(s)

  MAUDE report 22456030 ↗
• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, A SHOULDER REVISION WAS PLANNED ON (B)(6) 2025 FOR INFECTION. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 22373294 ↗
• InjuryMay 27, 2025Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem

  REVISION OF A 2009 REVERSE TOTAL SHOULDER REPLACEMENT. REASON FOR REVISION WAS NOTCHING. HUMERAL COMPONENT WAS LOOSE. COMPONENTS CHANGED: GLENOSPHERE, HUMERAL STEM, UHMWPE LINER. SINGLE SCREW ALSO REMOVED FROM BASEPLATE AS NOTCHING FROM STEM WAS HITTING.

  Patient problems: Joint Impingement; Joint Laxity

  MAUDE report 22087691 ↗
• InjuryMay 21, 2025Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  IN 1ST REVISION, GLENOSPHERE AND STEM REPLACED DUE TO DISLOCATION. PRIOR TO STRYKER ACQUISITION OF TORNIER/ WRIGHT.

  Patient problems: Joint Dislocation

  MAUDE report 22064893 ↗
• InjuryMar 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN INFECTION WAS FOUND IN THE KNEE AND SPINE IMPLANT, AND THE SHOULDER WAS ALSO SUSPECTED OF BEING INFECTED. THE REVISION SURGERY FOR REMOVING IMPLANTS WAS SCHEDULED ON (B)(6) 2025.

  Patient problems: Medical device site infection

  MAUDE report 21700368 ↗
• InjuryFeb 25, 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 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) 2024 A PATIENT REQUIRED REVISION SURGERY DUE TO INSTABILITY WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. REVISION PROCEDURE TYPE: REVISION STEMMED TOTAL REVERSE ARTHROPLASTY.

  Patient problems: Joint Laxity

  MAUDE report 21456722 ↗
• InjuryNov 18, 2024Unstable; Osseointegration Problem; Unstable; Osseointegration Problem

  PATIENT UNDERWENT RIGHT REVERSE SHOULDER REPLACEMENT. PATIENT INFORMED SURGEON AT THE TIME THAT HER RIGHT (PROSTHETIC) SHOULDER WAS BECOMING MORE PAINFUL OF LATE. X-RAYS / SCANS SHOWED A LOOSE GLENOID COMPONENT. DURING SURGERY OF RIGHT PROSTHETIC SHOULDER YESTERDAY, THICK BLOOD STAINED FLUID ASPIRATED FROM JOINT - POSSIBLE INFECTED JOINT, ACCORDING TO SURGEON. MULTIPLE TISSUE SAMPLES TAKEN. DECISION MADE TO REMOVE ALL COMPONENTS, EXCEPT THE WELL FIXED STEM. ALL OTHER COMPONENTS REMOVED. STEM (LEFT INSITU) WAS CONVERTED TO HEMI-ARTHROPLASTY. 2ND STAGE REVISION SURGERY WILL BE PLANNED FOR SOMETIME IN THE FUTURE, WHEN SURGEON DETERMINES SUITABILITY.

  Patient problems: Implant Pain; Inadequate Osseointegration; Unspecified Infection

  MAUDE report 20707631 ↗
• InjurySep 19, 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) 2022 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 20254543 ↗
• InjuryAug 20, 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) 2021 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. REVISION PROCEDURE TYPE: STAGE 1 OF 2 STAGE REVISION.

  Patient problems: Unspecified Infection

  MAUDE report 20006119 ↗
• InjuryApr 1, 2024Device 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) 2020 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION/DISLOCATION/SUBLUXATION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. REVISION PROCEDURE TYPE: DEBRIDEMENT AND IMPLANT RETENTION (DAIR).

  Patient problems: Joint Dislocation; Subluxation; Unspecified Infection

  MAUDE report 19011603 ↗
• InjuryMar 7, 2024Naturally Worn; Naturally Worn

  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 18862247 ↗
• InjuryMar 4, 2024Device 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 (B)(6) 2012 ¿ (B)(6) 2022. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2021 A PATIENT REQUIRED REVISION SURGERY DUE TO COMPONENT DISSOCIATION , WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. REVISION PROCEDURE TYPE: SINGLE STAGE REVISION.

  Patient problems: Joint Dislocation

  MAUDE report 18828147 ↗
• InjuryFeb 7, 2024Unstable; Device Dislodged or Dislocated; Naturally Worn; Unstable; Device Dislodged or Dislocated; Naturally Worn

  THE REVISION OF REVERSED II HCP STEM WAS NECESSARY DUE TO INSTABILITY ISSUES. IT WAS REPLACED WITH A CEMENTED STEM FEATURING A CONSTRAINED INSERT FOR ENHANCED STABILITY.

  Patient problems: Failure of Implant; Joint Dislocation; Joint Laxity

  MAUDE report 18659302 ↗
• InjuryJun 14, 2022Migration; Migration

  IT WAS REPORTED THAT THE PATIENT WAS INVOLVED IN A MOTOR VEHICLE ACCIDENT AND EXPERIENCED NEW ONSET OF SHOULDER PAIN AFTER THAT. THE X-RAYS SHOWED A SUBSIDENCE OF HUMERAL COMPONENT. THE PATIENT HAD THE INSERT AND GLENOSPHERE REVISED.

  Patient problems: Implant Pain

  MAUDE report 14684938 ↗
• InjuryFeb 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) 2017: PUS AT INSERTION SITE WAS SEEN. ALTHOUGH THE CRP WAS LOW, INFECTION WAS SUSPECTED. (B)(6) 2017: THE SITE WAS CLEANED, AND THE INSERT AND SPHERE WERE REPLACED WITH NEW ONES. THE DOCTOR SAID THAT THE PATIENT HAD BEEN TREATED FOR TOOTH DECAY AND HE MIGHT HAVE GOTTEN INFECTION FROM TOOTH DECAY TREATMENT.

  Patient problems: Unspecified Infection

  MAUDE report 13606846 ↗
• InjuryJun 3, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  SURGEON REMOVED REVERSED II STEM AND INSERT DUE TO NOTCHING OF SCAPULA. HE ALSO REMOVED THE GLENOSPHERE. REPLACEMENT GLENOSPHERE WAS OUR 10 DEGREE TILT AND THE STEM WAS REPLACED BY ANOTHER COMPANY MODEL. ISSUE NOTED INITIALLY WHEN REVIEWING X RAYS OF PATIENTS SHOULDER.

  Patient problems: Bone Shedding Debris

  MAUDE report 11931419 ↗
• InjurySep 9, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2020: THIS PATIENT BECAME PSEUDO-ARTICULATED AFTER A PROXIMAL HUMERUS FRACTURE AND HAD AN AEQUALIS REVERSE SURGERY. ON (B)(6) 2020: THE SURGEON FOUND A DISLOCATION BETWEEN THE INSERT AND THE GLENOID SPHERE. ON (B)(6) 2020: REVISION SURGERY WAS PERFORMED FOR THE REPLACEMENT OF THE INSERT AND THE GLENOID SPHERE. TO ADJUST THE TENSION, DWD989 AND DWD194, WERE NEWLY USED RESPECTIVELY. THE REMAINING IMPLANTS WERE TO CONTINUE TO BE USED AS THEY WERE.

  Patient problems: Joint Dislocation

  MAUDE report 10506684 ↗
• 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 10475817 ↗
• 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 9823316 ↗
• InjuryJan 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PATIENT HAD AN INITIAL SURGERY OF AEQUALIS REVERSED ON (B)(6) 2019. AFTER THE SURGERY, THE GLENOID SPHERE FELL OUT FROM THE BASEPLATE, AND THE DISLOCATION OCCURRED. THERE WAS A REVISION SURGERY ON (B)(6) 2019. THE GLENOID SPHERE AND THE INSERT WERE NEWLY REPLACED TO THE IMPLANTS WITH THE SAME PRODUCT NUMBER. ALSO THE SPACER (DWB) WAS USED THIS TIME, AND THE SURGERY WAS COMPLETED. THE SURGEON COMMENTED "THE DISLOCATION MIGHT OCCUR BECAUSE MY TIGHTENING WAS TOO LOOSE".

  Patient problems: Joint Dislocation

  MAUDE report 9610280 ↗
• InjuryNov 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  "AFTER THE INITIAL SURGERY OF AEGUALIS REVERSED, INFECTION BY E. COLI WAS FOUND IN THE AFFECTED AREA. ON (B)(6) 2019, A REVISION SURGERY WAS PERFORMED AND THE GLENOID SPHERE, THE INSERT AND THE SPACER WERE REPLACED."

  Patient problems: Unspecified Infection

  MAUDE report 9278766 ↗