AEQUALIS REVERSED DWD138Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 03700386917110), received between Apr 14, 2022 and Aug 3, 2026 — classified as 15 injuries, 1 malfunction.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryAug 3, 2026Osseointegration Problem

  It was reported that, originally revision surgery cancelled due to unknown reasons. It was rebooked for (b)(6)2026. Surgeon had planned to revise glenoid due to glenoid loosening during a recent fall. During case, surgeon identified that arthroplasty joint had been infected in his opinion. All humeral and glenoid components were removed without difficulty. Multiple tissue samples were taken. Debridement and copious lavage was performed. Antibiotic cement spacer was implanted for a two stage revision. Dr (b)(6) stated that there were no clinical markers indicative of joint infection. Second stage revision planned for 2-3 months. No further x-ray & CT available No pathology report available No other pt details available. Second stage procedure using competitor product.

  Patient problems: Fall; Inadequate Osseointegration; Unspecified Infection

  MAUDE report 50122219 ↗
• InjuryAug 3, 2026Osseointegration Problem

  It was reported that, originally revision surgery cancelled due to unknown reasons. It was rebooked for (b)(6) 2026. Surgeon had planned to revise glenoid due to glenoid loosening during a recent fall. During case, surgeon identified that arthroplasty joint had been infected in his opinion. All humeral and glenoid components were removed without difficulty. Multiple tissue samples were taken. Debridement and copious lavage was performed. Antibiotic cement spacer was implanted for a two stage revision. Dr (b)(6) stated that there were no clinical markers indicative of joint infection. Second stage revision planned for 2-3 months. No further x-ray & CT available No pathology report available. No other pt details available. Second stage procedure using competitor product.

  Patient problems: Fall; Inadequate Osseointegration; Unspecified Infection

  MAUDE report 50121687 ↗
• 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 22649309 ↗
• InjuryJul 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE PATIENT HAD PRIMARY LEFT SHOULDER REPLACEMENT ON (B)(6) 2022. THE PATIENT COMPLAINED OF PAIN, HAD ARTHROSCOPIC DEBRIDEMENT ON (B)(6) 2024, THE SPECIMENS TAKEN SHOWED INFECTED WITH C. ACNES BACTERIUM. MULTIPLE ARTHROSCOPIC WASHOUTS / DEBRIDEMENT PROCEDURES, WITH INSERTION OF ANTIBIOTIC BEADS INTO JOINT SPACE AND LONG TERM ANTIBIOTIC THERAPY, WITH LAST PROCEDURE ON (B)(6) 2025 . FURTHER SPECIMENS TAKEN DURING THIS PROCEDURE SHOWED PERSISTENT C. ACNES INFECTION, THOUGH SCANT. DURING THIS PROCEDURE, THE SURGEON MADE THE INTRA-OPERATIVE DECISION, TO REMOVE ALL PRIMARY IMPLANTS AND INSERT A ANTIBIOTIC SPACER, & CONTINUE ANTIBIOTIC (IV AND ORAL) THERAPY, AND HAVE A 2ND STAGE JOINT REPLACEMENT PROCEDURE IN THE FOLLOWING MONTHS, WHEN ALL CLINICAL MARKERS INDICATE THE INFECTION IS ABSENT.

  Patient problems: Bacterial Infection

  MAUDE report 22511866 ↗
• InjuryJul 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE PATIENT HAD PRIMARY LEFT SHOULDER REPLACEMENT ON (B)(6) 2022. THE PATIENT COMPLAINED OF PAIN, HAD ARTHROSCOPIC DEBRIDEMENT ON (B)(6) 2024, THE SPECIMENS TAKEN SHOWED INFECTED WITH C. ACNES BACTERIUM. MULTIPLE ARTHROSCOPIC WASHOUTS / DEBRIDEMENT PROCEDURES, WITH INSERTION OF ANTIBIOTIC BEADS INTO JOINT SPACE AND LONG TERM ANTIBIOTIC THERAPY, WITH LAST PROCEDURE ON (B)(6) 2025. FURTHER SPECIMENS TAKEN DURING THIS PROCEDURE SHOWED PERSISTENT C. ACNES INFECTION, THOUGH SCANT. DURING THIS PROCEDURE, THE SURGEON MADE THE INTRA-OPERATIVE DECISION, TO REMOVE ALL PRIMARY IMPLANTS AND INSERT A ANTIBIOTIC SPACER, & CONTINUE ANTIBIOTIC (IV AND ORAL) THERAPY, AND HAVE A 2ND STAGE JOINT REPLACEMENT PROCEDURE IN THE FOLLOWING MONTHS, WHEN ALL CLINICAL MARKERS INDICATE THE INFECTION IS ABSENT.

  Patient problems: Bacterial Infection

  MAUDE report 22509630 ↗
• InjuryMay 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  1ST STAGE REVISION OF AEQUALIS REVERSED II HUMERUS/ GLENOID DUE TO LONG STANDING INFECTION, AQUIRED 18 MONTHS POST INDEX SURGERY. SURGEON SAID IT WAS NOT PRODUCT FAULT. CAUSE OF INFECTION NOT RELATED TO PRODUCT. SIMPLY NOTIFYING THAT THESE PROSTHESIS WERE EXPLANTED. NATURE OF INFECTION AND BUG UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 22063797 ↗
• InjuryDec 30, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE STRYKER PROPHECY TEAM HAS RECEIVED A CT SCAN FOR THE UPCOMING REVISION SURGERY. THE REASON FOR THE REVISION IS UNSPECIFIED TRAUMA.

  Patient problems: Insufficient Information

  MAUDE report 21036830 ↗
• InjuryJun 12, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT REQUIRED REVISION SURGERY AFTER DISLODGMENT AND POSSIBLE INFECTION.

  Patient problems: Joint Dislocation; Unspecified Infection

  MAUDE report 19521909 ↗
• InjuryJun 12, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT REQUIRED REVISION SURGERY AFTER DISLODGMENT AND POSSIBLE INFECTION.

  Patient problems: Joint Dislocation; Unspecified Infection

  MAUDE report 19521892 ↗
• InjuryMar 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION OF REVERSE II GLENOID AND POLY LINER. THE GLENOID COMPONENT HAD BROKEN AWAY FROM THE GLENOID. THE GLENOSPHERE AND BASEPLATE HAD DISSOCIATED AND THERE WAS POLY WEAR. THE IMPLANTS WERE REMOVED AND REPLACED. A SCREW WAS USED TO REMOVE THE POLY LINER.

  Patient problems: Insufficient Information

  MAUDE report 18862179 ↗
• MalfunctionAug 18, 2023Break; Fracture; Break; Fracture

  IT WAS REPORTED "AFTER SCREWING THE PERIPHERAL SCREWS TO THE MOTOR, THE SURGEON FINISHED THE SCREWING PROCESS BY HAND. ON THE LAST SCREW, THE SCREW HEAD BROKE OFF. THE BODY OF THE SCREW WAS IN THE BASEPLATE, BUT THE HEAD REMAINED ON THE 4.5 TORQUE SCREWDRIVER."

  Patient problems: Foreign Body In Patient

  MAUDE report 17571647 ↗
• InjuryJul 21, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVERSE SHOULDER REPLACEMENT 10 YEARS AGO. ALLEGEDLY, THE PATIENT PRESENTED WITH PAIN AND A REVISION WAS SCHEDULED. DURING THE REVISION THE SITE APPEARED INFECTED. INVESTIGATIONS DONE AND BONE SCAN SHOWED HOT SPOT OVER THE GLENOID WHILE X RAY DEMONSTRATED GLENOID LOOSENING. GLENOID COMPONENT WAS LOOSE AND MEDIALISED AND ONE SCREW HAD BROKEN. GLENOID IMPLANT REMOVED, ALONG WITH THE POLY FROM THE HUMERAL COMPONENT. CULTURES TAKEN. CONVERTED TO A HEMI.

  Patient problems: Failure of Implant; Implant Pain; Unspecified Infection

  MAUDE report 15075886 ↗
• 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 14414137 ↗
• 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 14188150 ↗
• InjuryApr 14, 2022Migration; Migration

  IT WAS REPORTED THAT THE FLEX STEM WAS REVISED FOR LOOSENING DUE TO INFECTION. THE PATIENT WAS TREATED FOR INFECTION. THIS POTENTIALLY REDUCED THE FUNCTION AS THE STEM MOVED INTO THE VARUS.

  Patient problems: Unspecified Infection

  MAUDE report 14112312 ↗
• InjuryApr 14, 2022Migration; Migration

  IT WAS REPORTED THAT THE FLEX STEM WAS REVISED FOR LOOSENING DUE TO INFECTION. THE PATIENT WAS TREATED FOR INFECTION. THIS POTENTIALLY REDUCED THE FUNCTION AS THE STEM MOVED INTO THE VARUS.

  Patient problems: Unspecified Infection

  MAUDE report 14112184 ↗