AEQUALIS REVERSED DWD144Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03700386917127), received between Dec 29, 2021 and Sep 21, 2026 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 21, 2026Adverse Event Without Identified Device or Use Problem

  A revision surgery was performed as a result of a suspected infection after the patient fell.

  Patient problems: Fall; Post Operative Wound Infection

  MAUDE report 50841157 ↗
• InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE PATIENT WAS REVISED DUE TO AN INFECTION. ALL THE IMPLANTS WERE REMOVED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 22668366 ↗
• InjuryJul 29, 2025Break; Fracture; Osseointegration Problem; Break; Fracture; Osseointegration Problem

  IT WAS REPORTED THAT, 2 SCREWS BROKE (CATALOG# DWD138 AND DWD144) AND THE ENTIRE PROSTHESIS (BASEPLATE) WAS LOOSE. THE ISSUE WAS NOTICED BY X RAY. REQUIRED A REVISION PROCEDURE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22649387 ↗
• InjuryJan 9, 2025Unstable; Unstable

  PATIENT UNDERWENT PRIMARY LEFT REVERSE SHOULDER REPLACEMENT ON (B)(6) 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 21110806 ↗
• InjuryApr 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PATIENT UNDERWENT LEFT PRIMARY SHOULDER REPLACEMENT ON (B)(6) 2020. PATIENT PRESENTED TO SURGEON IN 2023, WITH A HISTORY OF A PAINFUL LEFT SHOULDER, AND A DISCHARGING SINUS (LEFT AXILLA). SWABS GREW THE BACTERIA C. ACNES. PLAN: REMOVE ALL PROSTHESIS (1ST STAGE) / INSERT AN ANTIBIOTIC CEMENT SPACER; RETURN IN SEVERAL MONTHS, WHEN CLINICAL MARKERS INDICATE INFECTION RESOLVED, AND IMPLANT A NEW PROSTHETIC LEFT SHOULDER JOINT(2ND STAGE). TODAY, ALL PROSTHESIS REMOVED, DISCARDED. MULTIPLE SPECIMENS TAKEN FOR PATHOLOGY"

  Patient problems: Bacterial Infection; Implant Pain

  MAUDE report 19153479 ↗
• MalfunctionFeb 25, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE MULTI DIRECTIONAL LOCKING SCREW BROKE 4.5MM X 44 ON THE REVERSED 2 GLENOID SYSTEM. THE SCREW WAS PUT IN ON HAND AND THE HEX HEAD SNAPPED OFF WITH THE MOST PROXIMAL LOCKING THREADS STILL ATTACHED. IF THE BASEPLATE IS TO BE REVISED THE SCREW WILL HAVE NO MEANS OF BEING BACKED OUT WITHOUT MIDAS REX/ DIAMOND TIPPED BURR. THE SCREW IS IN SITU AND THE LOCKING HEAD FELL ONTO THE FLOOR AFTER BEING REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13600168 ↗
• MalfunctionDec 29, 2021Break; Break

  LOCKING SCREW FROM REVERSE 2 GLENOID SYSTEM BROKE OFF WHEN TIGHTENING. THE 4.5MM X 44MM MULTIDIRECTIONAL SCREW USED WITH THE REVERSE 2 BASEPLATE WAS POWERED INTO THE BASEPLATE AT A SLOW SPEED AND ONCE THE LOCKING THREADS STARTED TO ENGAGE THE DRIVER WAS REMOVED, HOWEVER THE HEAD OF THE SCREW CAME OFF WITH THE DRIVER. THE LOCKING THREADS ON THE SCREW DID ENGAGE WITH THE LOCKING ISLET, HOWEVER IN A REVISION SITUATION THERE IS NO HEAD OF THE SCREW TO AID THE REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13107528 ↗