AEQUALIS REVERSED DWD132Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 03700386917103), received between Jan 16, 2018 and Sep 18, 2026 — classified as 22 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Fall; Post Operative Wound Infection

  MAUDE report 50826182 ↗
• InjuryJan 6, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT, THE PATIENT HAD A REVISION FOR A BIO-RSA GLENOID PATIENT WHICH HAD APPEARED TO HAVE A RE-ABSORBED. THE SURGEON REMOVED THE GLENOSPHERE AND BASEPLATE WITH EASE FROM THE GLENOID SOCKET AND PACKED IT FULL WITH FEMORAL HEAD ALLOGRAFT. THE TRAY AND POLY WERE REMOVED FROM THE FLEX STEM AND SURGEON PLACED A 50X16 COCR FLEX HUMERAL HEAD ONTO THE STEM TO TURN IT TO A HEMI. IT WAS REPORTED IN A FINAL REPORT FROM SURGEON, THE RIGHT SHOULDER PROSTHESIS WAS DISLOCATED WITH THE HUMERAL END LYING INFERIOR TO THE GLENOID PROSTHETIC MARGIN. EXTENSIVE OSTEOLYSIS SURROUNDING THE GLENOID COMPONENT.

  Patient problems: Subluxation

  MAUDE report 23976916 ↗
• InjuryJan 6, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT, THE PATIENT HAD A REVISION FOR A BIO-RSA GLENOID PATIENT WHICH HAD APPEARED TO HAVE A RE-ABSORBED. THE SURGEON REMOVED THE GLENOSPHERE AND BASEPLATE WITH EASE FROM THE GLENOID SOCKET AND PACKED IT FULL WITH FEMORAL HEAD ALLOGRAFT. THE TRAY AND POLY WERE REMOVED FROM THE FLEX STEM AND SURGEON PLACED A 50X16 COCR FLEX HUMERAL HEAD ONTO THE STEM TO TURN IT TO A HEMI. IT WAS REPORTED IN A FINAL REPORT FROM SURGEON, THE RIGHT SHOULDER PROSTHESIS WAS DISLOCATED WITH THE HUMERAL END LYING INFERIOR TO THE GLENOID PROSTHETIC MARGIN. EXTENSIVE OSTEOLYSIS SURROUNDING THE GLENOID COMPONENT.

  Patient problems: Subluxation

  MAUDE report 23976695 ↗
• InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, REVISION SURGERY WAS PERFORMED. 2 STAGE PROCEDURE AS LIKELY TO BE INFECTED. PRIMARY SURGERY WAS PERFORMED ON 3/6/22 WITH ASCEND FLEX AND REVERSE II IMPLANTS. ALL IMPLANTS WERE REMOVED AND PICTURED. A CEMENT SPACER WAS PLACED IN. IT WAS FURTHER REPORTED, THE PATIENT HAD PAIN AND SURGEON ORDERED X-RAYS (THESE WERE ATTACHED IN MY SUBMISSION) AND SURGEON NOTICED BONE REABSORPTION. DID NOT EXPECT INFECTION AS NO PATHOLOGY TESTS INDICATED IT. HOWEVER IN REVISION SURGEON THERE WAS STRONG EVIDENCE OF INFECTION WITH PUS AND INFECTED TISSUE.

  Patient problems: Implant Pain; Osteolysis; Unspecified Infection

  MAUDE report 23871281 ↗
• InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, REVISION SURGERY WAS PERFORMED. 2 STAGE PROCEDURE AS LIKELY TO BE INFECTED. PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2022, WITH ASCEND FLEX AND REVERSE II IMPLANTS. ALL IMPLANTS WERE REMOVED AND PICTURED. A CEMENT SPACER WAS PLACED IN.IT WAS FURTHER REPORTED, THE PATIENT HAD PAIN AND SURGEON ORDERED X-RAYS (THESE WERE ATTACHED IN MY SUBMISSION) AND SURGEON NOTICED BONE REABSORPTION. DID NOT EXPECT INFECTION AS NO PATHOLOGY TESTS INDICATED IT. HOWEVER IN REVISION SURGEON THERE WAS STRONG EVIDENCE OF INFECTION WITH PUS AND INFECTED TISSUE.

  Patient problems: Implant Pain; Osteolysis; Unspecified Infection

  MAUDE report 23871278 ↗
• InjuryAug 1, 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 22684216 ↗
• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY INCLUDING THE REMOVAL OF GLENOID IMPLANTS AND POLY LINER IN NEEDED DUE TO INFECTION. IT WAS ALSO REPORTED BY THE FACILITY THAT THE INFECTION HAD NOTHING TO DO WITH THE PRODUCT OR STERILITY OF THE PRODUCT.

  Patient problems: Unspecified Blood or Lymphatic problem; Unspecified Infection

  MAUDE report 22375076 ↗
• 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 22086974 ↗
• 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, ACQUIRED 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 22063765 ↗
• MalfunctionMar 31, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "SCREW HEAD BROKEN WHEN SCREWING INTO THE BASEPLATE. IMPLANT REMAINS IN PATIENT'S BODY. NO RECOGNIZABLE INFLUENCE ON THE SURGICAL RESULT."

  Patient problems: Foreign Body In Patient

  MAUDE report 21734518 ↗
• InjuryMar 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 21529355 ↗
• InjuryMar 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 21529349 ↗
• InjuryNov 18, 2024Unstable; Osseointegration Problem; Unstable; Osseointegration Problem

  PATIENT UNDERWENT RIGHT REVERSE SHOULDER REPLACEMENT. PATIENT INFORMED SURGEON AT THE TIME THAT HER RIGHT (PROSTHETIC) SHOULDER WAS BECOMING MORE PAINFUL OF LATE. X-RAYS / SCANS SHOWED A LOOSE GLENOID COMPONENT. DURING SURGERY OF RIGHT PROSTHETIC SHOULDER YESTERDAY, THICK BLOOD STAINED FLUID ASPIRATED FROM JOINT - POSSIBLE INFECTED JOINT, ACCORDING TO SURGEON. MULTIPLE TISSUE SAMPLES TAKEN. DECISION MADE TO REMOVE ALL COMPONENTS, EXCEPT THE WELL FIXED STEM. ALL OTHER COMPONENTS REMOVED. STEM (LEFT INSITU) WAS CONVERTED TO HEMI-ARTHROPLASTY. 2ND STAGE REVISION SURGERY WILL BE PLANNED FOR SOMETIME IN THE FUTURE, WHEN SURGEON DETERMINES SUITABILITY.

  Patient problems: Implant Pain; Inadequate Osseointegration; Unspecified Infection

  MAUDE report 20707491 ↗
• InjuryJul 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PATIENT UNDERWENT PRIMARY RIGHT SHOULDER REPLACEMENT, ON (B)(6) 2024, AT (B)(6) HOSPITAL, QLD. PATIENT UNDERWENT REVISION OF THIS SHOULDER JOINT, YESTERDAY ON (B)(6) 2024), AFTER A SHORT HISTORY OF PAIN, SWELLING, REDNESS OVER SURGICAL SITE. PT PRESENTED AT (B)(6) HOSPITAL LAST FRIDAY ON (B)(6) 2024), WITH THESE SIGNS, AND FEELING GENERALLY UNWELL. CLINICAL DIAGNOSIS OF INFECTION, AS PER SURGEON'S COMMENTS YESTERDAY (SAME SURGEON). REVISION SURGERY YESTERDAY CARRIED OUT AT (B)(6) HOSPITAL. WOUND OPENED, MULTIPLE SPECIMENS TAKEN AS SEVERAL IMPLANTS WERE REMOVED AND REPLACED, AFTER COPIOUS LAVAGE / DEBRIDEMENT. HUMERAL TRAY AND POLY REPLACED. ASCEND FLEX STEM LEFT INSITU (APPEARED TO BE SOLIDLY FIXED). GLENOSPHERE REPLACED. 3 OF THE 4 BASEPLATE SCREWS REPLACED (4TH SCREW UNABLE TO BE REMOVED). BASEPLATE LEFT INSITU - VERY SLIGHT MOVEMENT OF BASEPLATE NOTED, AFTER THE 3 X SCREWS REMOVED, BUT SURGEON DECIDED TO LEAVE IT INSITU, AND AFTER THE NEW SCREWS WERE IMPLANTED, THE BASEPLATE APPEARED SOLIDLY FIXED."

  Patient problems: Erythema; Implant Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 19810359 ↗
• 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 19521927 ↗
• 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 19153481 ↗
• InjuryMar 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD REVISION SURGERY DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 18903046 ↗
• InjuryDec 29, 2023Break; Fracture; Break; Fracture

  TORNIER SHOULDER OUTCOMES STUDY - SHOUT (SUBJECT (B)(6)) LOOSENING OF THE GLENOID COMPONENT BECAUSE OF A FALL DOWN OF THE PATIENT, GENERATING A GLENOID FRACTURE DATE OF EXPLANT: (B)(6) 2019 RESOLVED WITHOUT SEQUELAE: (B)(6) 2019 UPDATE: ACCORDING TO THE REPORTS AND AN HCP REVIEW, ONE OF THE 32MM SCREWS WAS BROKEN. IT IS UNKNOWN WHICH ONE.

  Patient problems: Bone Fracture(s); Failure of Implant; Fall

  MAUDE report 18419454 ↗
• InjuryDec 29, 2023Break; Fracture; Break; Fracture

  TORNIER SHOULDER OUTCOMES STUDY - SHOUT (SUBJECT 108-00045). LOOSENING OF THE GLENOID COMPONENT BECAUSE OF A FALL DOWN OF THE PATIENT, GENERATING A GLENOID FRACTURE. DATE OF EXPLANT: (B)(6) 2019. RESOLVED WITHOUT SEQUELAE: (B)(6) 2019. UPDATE: ACCORDING TO THE ATTACHED REPORTS AND AN HCP REVIEW, ONE OF THE 32MM SCREWS WAS BROKEN. IT IS UNKNOWN WHICH ONE.

  Patient problems: Bone Fracture(s); Failure of Implant; Fall

  MAUDE report 18419286 ↗
• InjuryNov 2, 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(B)(6) 2022. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2017 A PATIENT REQUIRED REVISION SURGERY DUE TO PERIPROSTHETIC FRACTURE, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Limb Fracture

  MAUDE report 18057460 ↗
• MalfunctionJun 28, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT 1X 4.5MM 32MM SUPERIOR MULTIDIRECTIONAL LOCKING SCREW HEAD BROKE OFF IN-SITU IN THE 25MM BASEPLATE. THE SCREW WAS INSERTED ON HAND AND BROKE OFF BEFORE THE THREADS WERE FULLY ENGAGED. THE SCREW HEAD WAS LEFT ON DRIVER AFTER THE DRIVER WAS DISENGAGED FROM THE BASEPLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14841479 ↗
• 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 14414145 ↗
• 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 14186354 ↗
• MalfunctionFeb 25, 2022Material Fragmentation; Material Fragmentation

  4TH AND FINAL SCREW, SECOND OF THE MULTIDIRECTIONAL, BEING INSERTED ON SCREWDRIVER DURING A REVERSE SHOULDER ARTHROPLASTY SHEARED ONCE THE THREAD HAD ENGAGED WITH THE RING INSIDE THE BASEPLATE. ANOTHER SCREW WAS AVAILABLE OF THE SAME SIZE, BUT THE SURGEON HAD CONCERN WITH REMOVING THE THREADED SCREW AND WAS SATISFIED WITH FIXATION SO LEFT IN SITU. SURGEON DID MENTION THE PATIENT HAD SCLEROTIC BONE AND THE GLENOID WAS UNUSUALLY HARD, FURTHERING HIS CONCERN ABOUT REMOVING AND REINSERTING ANOTHER SCREW.

  Patient problems: Failure of Implant

  MAUDE report 13606775 ↗
• MalfunctionFeb 23, 2022Break; Fracture; Break; Fracture

  HEAD OF MULTIDIRECTIONAL LOCKING SCREW 32MM BROKE WHEN FIXING IN AEQUALIS BASEPLATE 29MM. SCREW IS FIXED IN GLENOIDBONE AND IN THREAD OF BASEPLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13588086 ↗