AEQUALIS REVERSED II DWE835Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03700386952746), received between Aug 1, 2016 and May 21, 2021 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 21, 2021Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED ON (B)(6) 2021 DUE TO INSTABILITY POST REVERSE TOTAL SHOULDER REPLACEMENT (TORNIER THREADED POST BASEPLATE, SCREWS, GLENOSPHERE, TRAY AND INSERT REMOVED BY THE SURGEON IN DURANGO CO). TORNIER FLEX PTC 6B LONG STEM WAS REPORTED WELL FIXED BY THE SURGEON, SO RETAINED IN PATIENT. THE PATIENT WAS COMPLIANT TO MOBILIZATION INSTRUCTIONS OF THE SURGEON BUT NOT THE LONG TERM WEIGHT RESTRICTIONS. THE SURGEON DID NOT WANT TO PROVIDE THE CT SCANS. THE PATIENT WAS PULLING HOSES 9 MONTHS POST OP AND FELT A "POP" THAT WAS PRESUMABLY A DISLOCATION HE STATES, MULTIPLE SELF REPORTED DISLOCATIONS, NONE DOCUMENTED UNTIL LATE WINTER EARLY OF 2021. THE SURGEON WANTS TO MAKE SURE IT¿S CLEARLY UNDERSTOOD THAT HE HAS NO COMPLAINT AGAINST OUR PRODUCTS, JUST REPORTING AS ASKED OF A REVISION TOTAL SHOULDER. REVERSED INSERT WERE IMPLANTED.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 11866421 ↗
• InjuryOct 30, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  "THIS IS ONE OF DR (B)(6) PREVIOUS PATIENTS, NOW TAKEN CARE OF BY DR (B)(6). ORIGINALLY DR (B)(6) DID A BIORSA (BONE GRAFT) WITH A THREADED POST BASEPLATE. ON XRAY THERE WAS A SCREW-LIKE LUCENCY AROUND THE CENTRAL SCREW AS IF IT HAD WINDSHIELD-WIPERED ITS WAY LOOSE. PATIENT CAME IN WITH A DISLOCATED ADJUSTABLE REVERSE, WITH SOME OBVIOUSLY BROKEN SCREWS ON XRAY, AND RADIOLUCENCY AROUND THE SCREW ITSELF."

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 9257600 ↗
• InjuryNov 8, 2016Adverse 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 FOR BREAKAGE OF TWO OF THE PERIPHERAL LOCKING SCREWS OF THE BASEPLATE DUE TO A FALL ONTO AN OUTSTRETCHED ARM. GLENOID SPHERE AND BASEPLATE WERE REMOVED AND REPLACED WITH NEW COMPONENTS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED FOR THIS PATIENT.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6084887 ↗
• InjuryAug 11, 2016Adverse 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 LOOSENING/LYSIS. GLENOSPHERE AND BASEPLATE WERE REMOVED AND REPLACED WITH NEW COMPONENTS FROM ANOTHER MANUFACTURER. PATIENT ID: (B)(6).

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 5867909 ↗
• InjuryAug 1, 2016Material Separation; Material Separation

  REVISION SURGERY DUE TO IMPLANT BREAKAGE - GLENOID. PATIENT ID: (B)(6).

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 5836166 ↗