AEQUALIS REVERSED DWB940Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 03700386916175), received between Aug 23, 2017 and May 27, 2025 — classified as 11 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMay 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use 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 22086965 ↗
• InjuryMar 4, 2024Osseointegration Problem; Osseointegration 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES WITH THE TORNIER SHOULDER SYSTEM.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 APRIL 2012 ¿ MAY 2022. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON 02-NOVEMBER-2018 A PATIENT REQUIRED REVISION SURGERY DUE TO ASEPTIC LOOSENING HUMERUS, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. REVISION PROCEDURE TYPE: SINGLE STAGE REVISION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18825788 ↗
• InjuryOct 10, 2023Adverse 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES WITH THE TORNIER SHOULDER SYSTEM.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 APRIL 2012 ¿ MAY 2022. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2020 A PATIENT REQUIRED REVISION SURGERY DUE UNEXPLAINED PAIN, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. REVISION PROCEDURE TYPE : SINGLE STAGE REVISION.

  Patient problems: Implant Pain

  MAUDE report 17909715 ↗
• InjuryFeb 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) 2015 INITIAL SURGERY: (B)(6) INFECTION: (B)(6) 2015 RE-SURGERY (MEANS SURGICAL OPERATION WITHOUT ANY IMPLANT COMPONENT CHANGE, ONLY CLEANING. NO DEVICE WAS EXPLANTED). (B)(6) 2015 BLOOD CRP RETURNED NORMAL.

  Patient problems: Unspecified Infection

  MAUDE report 13606759 ↗
• InjuryJun 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS AN AEQUALIS REVERSE POST APPROVAL STUDY REPORT. ON (B)(6) 2014: A CRACK OCCURRED DURING THE PROXIMAL HUMERUS TREATMENT DURING THE AEQUALIS REVERSE SURGERY. THE ENTIRE AREA AROUND THE FISSURE WAS SECURED WITH STRONG SUTURE THREAD AND THE SURGERY WAS COMPLETED.

  Patient problems: Bone Fracture(s)

  MAUDE report 12046366 ↗
• InjuryMay 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS AN AEQUALIS REVERSE POST APPROVAL STUDY REPORT 13-22. (B)(6) 2014, INTRAOPERATIVELY, A CRACK OCCURRED IN THE PROXIMAL HUMERUS AND WAS TREATED, BUT A HUMERAL FRACTURE OCCURRED SHORTLY AFTER. THE HUMERUS WAS TREATED WITH A CEMENTED FIXATION STEM AND THE SURGERY WAS COMPLETED. POSTOPERATIVELY, THE PATIENT IS DOING FINE AND IS ATTENDING REGULARLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 11877639 ↗
• InjuryMay 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS AN AEQUALIS REVERSE POST APPROVAL STUDY REPORT 9-04. AFTER THE PATIENT HAD AN INITIAL SURGERY OF AEQUALIS REVERSE ON (B)(6) 2014, A HAND TREMOR WAS CONFIRMED. A WAIT-AND-SEE APPROACH WAS TAKEN.

  Patient problems: Shaking/Tremors

  MAUDE report 11877584 ↗
• InjuryMay 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS AN AEQUALIS REVERSE POST APPROVAL STUDY REPORT 9-02. AFTER THE PATIENT HAD AN INITIAL SURGERY OF AEQUALIS REVERSE ON (B)(6) 2014, A NUMBNESS IN THE HANDS WAS CONFIRMED ON (B)(6) 2014, BUT A WAIT-AND-SEE APPROACH WAS TAKEN. SINCE IT DIDN'T SEEM TO HAVE ANY FUNCTIONAL IMPACT, SO THE SURGEON DECIDED TO OBSERVE THE SITUATION AS IT WAS.

  Patient problems: Numbness

  MAUDE report 11876630 ↗
• InjurySep 6, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  FOLLOWING THE SURGERY WHERE THESE REVERSE II IMPLANTS WERE IMPLANTED (ANOTHER HOSPITAL IN (B)(6)), THE PATIENT UNDERWENT A FOLLOW UP SCAN AND IT WAS IDENTIFIED THAT THE REVERSED II STEM AND METAPHYSIS COMPONENTS WERE DETACHED/DETACHING (UNSCREWED). THIS PATIENT WAS THEN REFERRED TO MR (B)(6) AT (B)(6) TO REVISE AND FIX THIS ISSUE. MR (B)(6) WAS ABLE TO REMOVE THESE COMPONENTS.

  Patient problems: Joint Dislocation

  MAUDE report 8969045 ↗
• InjuryJul 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  "THIS PATIENT HAD AN INITIAL SURGERY OF ASCEND FLEX RSA ON (B)(6) 2014. THE IMPLANTS USED IN THIS SURGERY WERE (DWB940), (DWB960), (DWB993), (DWD180), (DWD170), (VDV118), (VDV126), (DWD120)×2. AND AFTER FOUR YEARS AND SEVEN MONTHS, WHEN THE PATIENT HAD AN X-RAY ON (B)(6) 2019, FRACTURE OF THE HUMERAL BONE FRACTURE WAS FOUND. REVISION SURGERY PERFORMED ON (B)(6) 2019."

  Patient problems: Bone Fracture(s)

  MAUDE report 8800570 ↗
• InjuryAug 23, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT BROKE THE DIAPHYSEAL BONE DUE TO A FALL AND HAD SURGERY ON (B)(6) 2017. THE IMPLANTS INSERTED ON (B)(6) 2016 WERE NOT REMOVED AND A PLATE WAS USED TO FIX THE BROKEN BONE. THE SURGEON CONSIDERED ABOUT REPLACING THE STEM TO LONG STEM BUT CONDITION OF PATIENT'S BONE WAS NOT SUITABLE FOR IT SO HE USED A PLATE INSTEAD.

  Patient problems: Fall

  MAUDE report 6812845 ↗