AEQUALIS REVERSED DWB945Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 03700386916212), received between Mar 24, 2017 and Feb 12, 2026 — classified as 14 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 16, 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.

• InjuryFeb 12, 2026Device 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES PERFORMED BETWEEN (B)(6) 2023 - (B)(6) 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024 A PATIENT REQUIRED REVISION SURGERY DUE TO COMPONENT DISSOCIATION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Subluxation

  MAUDE report 24323362 ↗
• InjuryMar 29, 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES WITH THE TORNIER SHOULDER SYSTEM.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 19003943 ↗
• InjuryMar 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD REVISION SURGERY DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 18903034 ↗
• InjuryDec 22, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED: "STEM LOOSENING. ADVERSE CONSEQUENCES REPORTED: INFECTION AND REVISION SURGERY".

  Patient problems: Unspecified Infection

  MAUDE report 18387322 ↗
• InjuryApr 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT (B)(4) UNDERWENT A REVISION SURGERY OF THE COMPLETE HUMERAL AND GLENOID SIDES DUE TO CALCIFIC PSEUDOTUMOR. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Seroma

  MAUDE report 16778837 ↗
• InjuryApr 20, 2023Migration; Migration

  IT WAS REPORTED THAT PATIENT (B)(6) UNDERWENT A REVISION SURGERY OF THE COMPLETE HUMERAL AND GLENOID SIDES DUE TO LOOSENING/LYSIS. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Osteolysis

  MAUDE report 16776074 ↗
• MalfunctionAug 31, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE METAPHYSEAL COMPONENT OF REV 2 HUMUROUS SEPARATED FROM THE STEM COMPONENT IN THE PATIENTS RIGHT SHOULDER. A REVISION SURGERY WAS PERFORMED. THE SURGEON REMOVED THE SEPARATED METAPHYSEAL COMPONENT AND THE STEM. THEY WERE REPLACED WITH NEW COMPONENTS.

  Patient problems: Failure of Implant

  MAUDE report 15331969 ↗
• InjuryJul 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO AN INFECTION 12 MONTHS POST-OP. THE METAL DEVICES WERE REMOVED AND A COMPETITOR'S CEMENT SPACER WAS INSERTED.

  Patient problems: Unspecified Infection

  MAUDE report 15043946 ↗
• InjuryFeb 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FIST INFECTION REFER TO MDR# 3000931034-2021-00065. ON (B)(6) 2015: RSA FOR ROTATOR CUFF TEAR. ON (B)(6) 2016: SUSPICION OF ARTHRITIS WITH SUPPURATION. DATA OF CRP, INFLAMMATION TEST, WAS 7. ON (B)(6) 2016: FOR THE ARTHRITIS WITH SUPPURATION, INSERT, SPHERE AND BASEPLATE WERE REMOVED, AND SURGEON DID DEBRIDEMENT AND FILLED WITH A CEMENT INCLUDING ANTIBIOTICS WITHOUT IMPLANTS REPLACEMENT (REFER TO MDR#3000931034-2021-00065). INFECTION FOR THE SECOND TIME, WITH SAME PATIENT: (B)(6) 2016: THE PATIENT WAS FOUND WITH THE SAME TYPE OF INFECTION THE STEM WAS REMOVED AND THE SPACE WAS FILLED WITH A CEMENT WITH ANTIBIOTICS. NO IMPLANT REPLACEMENT WAS DONE.

  Patient problems: Unspecified Infection

  MAUDE report 13606998 ↗
• InjuryFeb 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FROM THE AEQUALIS REVERSE POST APPROVAL STUDY RESULT RESEARCH,IT WAS CONFIRMED THAT THERE WAS A PATIENT WHO HAD A SUPERFICIAL INFECTION AFTER THE AEQUALIS REVERSE SURGERY ON (B)(6) 2015.

  Patient problems: Unspecified Infection

  MAUDE report 13606763 ↗
• 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 10475815 ↗
• InjuryApr 9, 2020Adverse 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 A PERIPROSTHETIC FRACTURE 8 YEARS AFTER PREVIOUS SURGERY. PATIENT ID: (B)(6).

  Patient problems: Bone Fracture(s)

  MAUDE report 9942956 ↗
• InjuryJan 30, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT REACHED OUT TO WRIGHT VIA (B)(6) PERSONAL MESSAGE. PROVIDED A PDF WITH DESCRIPTION OF INCIDENT AND X-RAYS: "SINCE (B)(6) 2017, I HAVE A NEW AEQUALIS REVERSED II SHOULDER SYSTEM, THANKS TO WHICH, AFTER SEVERAL MONTHS OF PHYSIOTHERAPY, I WAS ABLE TO RAISE MY ARM AGAIN AFTER 17 YEARS OF NOT BEING ABLE TO DO IT. I FELT VERY HAPPY WITH MY NEW PROSTHESES BECAUSE I COULD PRACTICE CYCLING AGAIN, BUT A MONTH AGO, ON (B)(6) 2018, AFTER CLIMBING TWO FLOORS WITH A FOURTEEN POUNDS SUITCASE IN EACH ARM, (15 LBS. EACH), THE RX SHOWED THE BROKEN AND DISASSEMBLED PROSTHESIS. COULD SOMEONE OF WRIGHT MEDICAL GROUP EXPLAIN TO ME WHY THIS FAULT HAPPENED AND WHAT IS THE PROCEDURE TO FOLLOW? MY DOCTOR IS BAFFLED SINCE HE HAD NEVER SEEN A SIMILAR PROSTHESIS DISASSEMBLY AND I AM COMPLETELY INCAPACITATED. ON (B)(6) 2018, THE PATIENT COULDN'T RAISE ARM AFTER CARRYING 2 SUITCASES UP 2 FLOORS. THE REVISION SURGICAL INTERVENTION WAS PLANNED FOR (B)(6) 2018, BUT MY SURGEON PREFERRED TO CONSULT MY CASE WITH THE BEST SURGEONS IN THE WORLD IN THE (B)(6) INTERNATIONAL SHOULDER COURSE ON (B)(6) 2019. "

  Patient problems: Joint Dislocation

  MAUDE report 8288408 ↗
• InjurySep 14, 2018Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  "SUBJECT HAD TENDERNESS OVER HUMERAL SHAFT. XRAYS REVEALED LOOSENING SIGNS AND LUCENCY OF THE HUMERAL COMPONENT ALONG THE CEMENT MANTLE. PATIENT ID: (B)(6)."

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7876494 ↗
• 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 6432092 ↗