AEQUALIS REVERSED II DWD989Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03700386932748), received between Nov 22, 2017 and Sep 16, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

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

  As reported: "Patient has re-presented to surgeon, following revision shoulder arthroplasty in (b)(6) 2026. Significant swelling and redness over wound, pain on movement. Wound re-opened, and surgeon concluded that the prosthetic joint was now infected. Decided to remove all prosthesis, as stage 1 of a 2-stage revision. Glenoid component was found to be very loose, easily removed as 1 x construct (revised at previous revision). Humeral component (not revised at previous revision) was found to be extremely well fixed. Humeral poly insert removed - significant wear noted (only been insitu since (b)(6) '26 revision). Proximal humeral vertical osteotomy was required to loosen and to break the bone / implant on growth. Stem eventually removed; osteotomy cabled back together with Nice Loops. Multiple tissue specimens collected; debridement; copious lavage attended; no antibiotic spacer implanted - gleno-humeral joint left dis-articulated.Plan - antibiotic regime until clinical markers indicate no infection, then the 2nd stage revision will be undertaken, using a "Custom Glenoid", to be manufactured by a competitor company."

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 50790675 ↗
• InjuryJan 9, 2025Unstable; Unstable

  PATIENT UNDERWENT PRIMARY LEFT REVERSE SHOULDER REPLACEMENT ON 27.3.2019. SURGEON STATES THAT PROSTHETIC JOINT HAS BEEN FUNCTIONING WELL, UNTIL APPROXIMATELY 6 MONTHS AGO, WHEN PATIENT EXPERIENCED SUDDEN ONSET OF PAIN, AND INCREASING INSTABILITY (PATIENT HAD BEEN DOING EXERCISES WITH WEIGHTS). DURING SURGERY, PROSTHETIC JOINT WAS FOUND TO BE VERY LAX, EASILY DISLOCATED, WITH SUB-SCAPULARIS TENDON RUPTURED. SURGEON REPAIRED SUB-SCAP., PLUS TENDON GRAFT / REPAIR, THEN REMOVED THE 9MM HUMERAL POLY INSERT, REPLACING THIS WITH A 9MM SPACER PLUS A NEW 9MM POLY INSERT. ADDITIONAL INFORMATION - THE LOCKING SCREW THAT CAME WITH THE 36MM SPACER, WOULD NOT ENGAGE WITH THE IMPLANT. THE 42MM SPACER WAS OPENED TO ACCESS ANOTHER LOCKING SCREW. THIS SCREW WAS FOUND TO ENGAGE THE IMPLANTED METAPHYSIS, LOCKING THE IMPACTED SPACER TO THE METAPHYSIS. THE FAULTY LOCKING SCREW IS AVAILABLE FOR RETURN. JOINT WAS FOUND TO BE STABLE THROUGH FULL RANGE OF MOVEMENT, SOFT TISSUE ENVELOP RECONSTRUCTED (SEPARATE COMPLAINT RAISED FOR SCREW).

  Patient problems: Implant Pain; Joint Laxity; Muscle/Tendon Damage

  MAUDE report 21110813 ↗
• InjuryApr 21, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LEFT REVERSE SHOULDER REPLACEMENT ON (B)(6) 2023. PATIENT'S SHOULDER DISLOCATED TWO DAYS LATER, WHICH WAS MANIPULATED AND A CLOSED REDUCTION ACHIEVED. PATIENT AGAIN DISLOCATED THEIR PROSTHETIC SHOULDER TWO DAYS LATER. DECISION MADE TO OPEN WOUND UP, AND DETERMINE CAUSE OF INSTABILITY. ALSO, PATIENT'S WOUND RETURNED A POSITIVE SWAB FOR "COLONIZATION" ACCORDING TO SURGEON. DURING SURGERY, MULTIPLE TISSUE SPECIMENS WERE TAKEN, FOR PATHOLOGY. AN OSTEOPHYTE OF THE POSTERO-SUPERIOR ASPECT OF THE PROXIMAL HUMERUS WAS IDENTIFIED AS THE LIKELY CAUSE OF THE RANGE OF MOTION IMPINGEMENT, LEADING TO INSTABILITY / DISLOCATION. THIS WAS REMOVED; THE GLENOSPHERE WAS EXCHANGED (AS THERE WERE MINOR SCRATCHES ON THE POLISHED SURFACE). THE 6MM POLY WAS ALSO EXCHANGED FOR A 9MM POLY, WHICH CONFERRED GREATER STABILITY, AND ADEQUATELY TENSIONED THE JOINT. STABLE RANGE OF MOTION OBTAINED; WOUND CLOSED. BOTH EXPLANTED PROSTHESIS DISCARDED BY SCRUB NURSE.

  Patient problems: Joint Dislocation; Unspecified Infection

  MAUDE report 16792049 ↗
• InjuryMay 16, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN OPEN SHOULDER SYNOVECTOMY/DEBRIDEMENT PROCEDURE DUE TO HAVING A SEPTIC RIGHT SHOULDER INFECTION POSSIBLY CAUSED BY METALLOSIS DUE TO THE IMPLANT LOOSENING.

  Patient problems: Metal Related Pathology; Unspecified Infection

  MAUDE report 14408407 ↗
• InjuryApr 22, 2022Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT ATTENDED A REVISION SURGERY FOR A REVERSE II IMPLANT, IMPLANTED IN 2014. THE PATIENT REPORTED WITH PAIN, LOOSENING AND INFECTION. IT'S POSSIBLE THAT THE INFECTION WAS CAUSED BY METALOSIS DUE TO IMPLANT LOOSENING.

  Patient problems: Bacterial Infection; Implant Pain; Metal Related Pathology

  MAUDE report 14186458 ↗
• InjurySep 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) 2020 ; AN INFECTION WAS CONFIRMED IN THE AFFECTED AREA. (B)(6) 2020: REVISION SURGERY WAS PERFORMED. THE GLENOID SPHERE AND THE INSERT WERE REPLACED TO PREVENT DISLOCATION AND THE SURGERY WAS COMPLETED. WHEN THE EACH IMPLANTS WERE REPLACED, THE GLENOID SPHERE NEWLY USED WAS THE SAME DATA AS LAST TIME, BUT THE INSERT WAS CHANGED TO DWD990 THIS TIME.

  Patient problems: Unspecified Infection

  MAUDE report 10565767 ↗
• InjuryNov 22, 2017Disassembly; Device Dislodged or Dislocated; Disassembly; Device Dislodged or Dislocated

  "ON (B)(6) 2015: SURGERY FROM TSA TO RSA DUE TO RCT WAS DONE./ (B)(6) 2015: SHOULDER DISLOCATION (NO SURGERY, MANUAL REDUCTION) / (B)(6) 2015: INSERT AND SPHERE WERE REPLACED DUE TO INSTABILITY. LATISSIMUS DORSI TRANSFER WAS DONE. / (B)(6) 2017: SHOULDER DISLOCATION (B)(6) 2017: INSERT WAS REPLACED. THE SURGEON THINKS THAT LOOSENING OF DELTOID MUSCLE HAS CAUSED THE SHOULDER DISLOCATION. "

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7052186 ↗