AEQUALIS REVERSED DWB960Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 03700386916328), received between Sep 28, 2016 and Nov 12, 2025 — classified as 24 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryNov 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE PRODUCT WAS IMPLANTED IN 2016. LATER, HE DEVELOPED INFECTION ON AN UNKNOWN DATE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2025, THEY REMOVED THE IMPLANT AND IMPLANTED A CEMENT MOLD.

  Patient problems: Unspecified Infection

  MAUDE report 23534432 ↗
• 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 22086977 ↗
• InjuryMar 27, 2024Adverse 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES WITH THE TORNIER SHOULDER SYSTEM.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 APRIL 2012 ¿ MAY 2022. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2021 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 18987426 ↗
• InjuryMar 5, 2024Unstable; Unstable

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES WITH THE TORNIER SHOULDER SYSTEM.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)2012 ¿ (B)(6) 2022. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2019 A PATIENT REQUIRED REVISION SURGERY DUE TO INSTABILITY, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Joint Laxity

  MAUDE report 18842219 ↗
• InjuryMar 4, 2024Osseointegration Problem; Osseointegration 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 APRIL 2012 ¿ MAY 2022. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2018 A PATIENT REQUIRED REVISION SURGERY DUE TO ASEPTIC LOOSENING HUMERUS, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. REVISION PROCEDURE TYPE: SINGLE STAGE REVISION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18828154 ↗
• InjuryOct 10, 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 APRIL 2012 ¿ MAY 2022. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2020 A PATIENT REQUIRED REVISION SURGERY DUE UNEXPLAINED PAIN, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. REVISION PROCEDURE TYPE : SINGLE STAGE REVISION.

  Patient problems: Implant Pain

  MAUDE report 17908318 ↗
• InjuryAug 31, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE METAPHYSEAL COMPONENT OF REV 2 HUMUROUS SEPARATED FROM THE STEM COMPONENT IN THE PATIENTS RIGHT SHOULDER. A REVISION SURGERY WAS PERFORMED. THE SURGEON REMOVED THE SEPARATED METAPHYSEAL COMPONENT AND THE STEM. THEY WERE REPLACED WITH NEW COMPONENTS.

  Patient problems: Failure of Implant

  MAUDE report 15332117 ↗
• InjuryJul 18, 2022Adverse 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 AN INFECTION 12 MONTHS POST-OP. THE METAL DEVICES WERE REMOVED AND A COMPETITOR'S CEMENT SPACER WAS INSERTED.

  Patient problems: Unspecified Infection

  MAUDE report 15043815 ↗
• InjuryJun 16, 2021Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  A DISSOCIATION BETWEEN METAPHYSEAL COMPONENT AND STEM. TORNIER PRIMARY SHOULDER AEQUALIS REVERSED II.

  Patient problems: Failure of Implant

  MAUDE report 12014197 ↗
• InjuryJun 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS AN AEQUALIS REVERSE POST APPROVAL STUDY REPORT. ON (B)(6) 2015: DURING THE AEQUALIS REVERSE INITIAL SURGERY, THE HUMERUS FRACTURED SLIGHTLY WHEN THE IMPLANT WAS INSERTED. AT THE DISCRETION OF THE SURGEON, NO SPECIFIC TREATMENT WAS GIVEN.

  Patient problems: Bone Fracture(s)

  MAUDE report 12010290 ↗
• InjuryNov 30, 2020Break; Break

  "PATIENT PUT HIMSELF UP FROM A CHAIR AND DURING THAT MOMENT HE FELT A BREAKAGE OF THE IMPLANT. (B)(6) PATIENT IS LIVING IN (B)(6), AFTER THE INCIDENT HE FLEW BACK TO (B)(6). THE SURGEON WHO GAVE HIM THE REVERSED 2 IMPLANT 9 YEARS AGO HAD NO POSSIBILITIES TO OPERATE HIM, SO PATIENT WENT TO DR (B)(6). HE INDICATES A BREAKAGE OF THE BROKEN SCREW THREAD OF THE CONNECTION SCREW THREADS OF REVERSED 2 METAPHYSIS. DURING SURGERY WE OBSERVED A BREAKAGE EXACTLY AT THE POINT OF THE PE STICK FROM THE CONNECTION. WE HAVE EXTRACTED THE METAPHYSIS, THEN WE TOOK THE PE STICK WITH A CLAMP AND UNSCREW IT FROM THE STEM. WE COULD SUCCESSFULLY EXTRACT THE STEM FROM THE HUMERUS. WE HAVE EXTRACTED THE REVERSED 2 STEM, WE HAVE TRIED TO EXTRACT THE CEMENT, BUT UNFORTUNATELY IT WAS NOT POSSIBLE TO EXTRACT IT IN TOTAL. THEREFORE THE SURGEONS MADE THE CHOICE TO IMPLANT A CEMENTED REVERSED FRACTURE STEM IN THE DISTAL PART OF THE OLD CEMENT MANTLE. WE ALSO CHANGED THE GLENOSPHERE BECAUSE THERE WAS A LOT OF METALLOSIS AND SCAPULA NOTCHING. WE HAVE CLEANED THE BASEPLATE AND PLACE A NEW GLENOSPHERE."

  Patient problems: Failure of Implant

  MAUDE report 10918102 ↗
• InjurySep 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, THIS PATIENT HAD AN INITIAL SURGERY OF AEQUALIS REVERSE AT (B)(6) ORTHOPEDICS HOSPITAL. ON (B)(6) 2020, AN INFECTION WAS FOUND AT THE AFFECTED PART AT THE SAME HOSPITAL. ON (B)(6) 2020, A REVISION SURGERY WAS PERFORMED AT (B)(6) MEDICAL CENTER. AFTER REMOVING ALL THE IMPLANTS,THE MOLD CEMENT WHICH INCLUDES ANTIBIOTICS WAS IMPLANTED TO THE HUMERAL AND THE SURGERY WAS COMPLETED. AFTER SEVERAL MONTHS OF FOLLOW-UP, ANOTHER REVISION SURGERY MIGHT BE PERFORMED FOR NEW IMPLANTS DEPENDING ON THE RECOVERY SITUATION.

  Patient problems: Unspecified Infection

  MAUDE report 10475814 ↗
• InjuryMay 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS DRIVING HER CAR WHEN SHE SUDDENLY FELT A 'KNACK'  FOLLOWED  BY AN IMMEDIATELY PAIN. XRAY SHOWED A DISENGAGEMENT OF THE REVERSED HEMI ADAPTER OF THE METAPHYSIAL COMPONENT. REVISION SURGERY PERFORMED ON (B)(6) 2020.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 10086734 ↗
• InjuryApr 9, 2020Adverse 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 DUE TO A PERIPROSTHETIC FRACTURE 8 YEARS AFTER PREVIOUS SURGERY. PATIENT ID: (B)(6).

  Patient problems: Bone Fracture(s)

  MAUDE report 9942953 ↗
• InjurySep 6, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  FOLLOWING THE SURGERY WHERE THESE REVERSE II IMPLANTS WERE IMPLANTED (ANOTHER HOSPITAL IN UK), THE PATIENT UNDERWENT A FOLLOW UP SCAN AND IT WAS IDENTIFIED THAT THE REVERSED II STEM AND METAPHYSIS COMPONENTS WERE DETACHED/DETACHING (UNSCREWED). THIS PATIENT WAS THEN REFERRED TO (B)(6) TO REVISE AND FIX THIS ISSUE. (B)(6) WAS ABLE TO REMOVE THESE COMPONENTS.

  Patient problems: Joint Dislocation

  MAUDE report 8969044 ↗
• InjuryJul 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  "THIS PATIENT HAD AN INITIAL SURGERY OF ASCEND FLEX RSA ON (B)(6) 2014. THE IMPLANTS USED IN THIS SURGERY WERE (DWB940), (DWB960), (DWB993), (DWD180), (DWD170), (VDV118), (VDV126),(DWD120)×2. AND AFTER FOUR YEARS AND SEVEN MONTHS, WHEN THE PATIENT HAD AN X-RAY ON (B)(6) 2019, FRACTURE OF THE HUMERAL BONE FRACTURE WAS FOUND. REVISION SURGERY PERFORMED ON (B)(6) 2019."

  Patient problems: Bone Fracture(s)

  MAUDE report 8800574 ↗
• InjuryMar 20, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DISENGAGEMENT OF THE EPIPHYSIS FROM THE DIAPHYSIS. UNSCREWED COMPONENTS AND REVISION NEEDED.

  Patient problems: Joint Dislocation

  MAUDE report 8436999 ↗
• InjuryJan 30, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT REACHED OUT TO WRIGHT VIA (B)(6) PERSONAL MESSAGE. PROVIDED A PDF WITH DESCRIPTION OF INCIDENT AND X-RAYS: "SINCE (B)(6) 2017, I HAVE A NEW AEQUALIS REVERSED II SHOULDER SYSTEM, THANKS TO WHICH, AFTER SEVERAL MONTHS OF PHYSIOTHERAPY, I WAS ABLE TO RAISE MY ARM AGAIN AFTER 17 YEARS OF NOT BEING ABLE TO DO IT. I FELT VERY HAPPY WITH MY NEW PROSTHESES BECAUSE I COULD PRACTICE CYCLING AGAIN, BUT A MONTH AGO, ON (B)(6) 2018, AFTER CLIMBING TWO FLOORS WITH A FOURTEEN POUNDS SUITCASE IN EACH ARM, (15 LBS. EACH), THE RX SHOWED THE BROKEN AND DISASSEMBLED PROSTHESIS. COULD SOMEONE OF WRIGHT MEDICAL GROUP EXPLAIN TO ME WHY THIS FAULT HAPPENED AND WHAT IS THE PROCEDURE TO FOLLOW? MY DOCTOR IS BAFFLED SINCE HE HAD NEVER SEEN A SIMILAR PROSTHESIS DISASSEMBLY AND I AM COMPLETELY INCAPACITATED. ON (B)(6) 2018, THE PATIENT COULDN'T RAISE ARM AFTER CARRYING 2 SUITCASES UP 2 FLOORS. THE REVISION SURGICAL INTERVENTION WAS PLANNED FOR (B)(6) 2018, BUT MY SURGEON PREFERRED TO CONSULT MY CASE WITH THE BEST SURGEONS IN THE WORLD IN THE (B)(6) INTERNATIONAL SHOULDER COURSE ON (B)(6) 2019. "

  Patient problems: Joint Dislocation

  MAUDE report 8288409 ↗
• InjuryAug 23, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT BROKE THE DIAPHYSEAL BONE DUE TO A FALL AND HAD SURGERY ON (B)(6) 2017. THE IMPLANTS INSERTED ON (B)(6) 2016 WERE NOT REMOVED AND A PLATE WAS USED TO FIX THE BROKEN BONE. THE SURGEON CONSIDERED ABOUT REPLACING THE STEM TO LONG STEM BUT CONDITION OF PATIENT'S BONE WAS NOT SUITABLE FOR IT SO HE USED A PLATE INSTEAD.

  Patient problems: Fall

  MAUDE report 6812843 ↗
• InjuryMay 10, 2017Adverse Event Without Identified Device or Use Problem; Missing Value Reason; Adverse Event Without Identified Device or Use Problem; Missing Value Reason

  SINCE THE PATIENT HAD INFECTION, ALL IMPLANTS WERE REMOVED AND THE INSERTION SITE WAS FILLED WITH A CEMENT CONTAINING ANTIBIOTICS. THE PATIENT RECEIVED CONSERVATIVE TREATMENT.

  Patient problems: Unspecified Infection

  MAUDE report 6556568 ↗
• InjuryMar 24, 2017Adverse Event Without Identified Device or Use Problem; Missing Value Reason; Adverse Event Without Identified Device or Use Problem; Missing Value Reason

  THE PATIENT COMPLAINED PAIN 16 MONTHS AFTER THE OPERATION AND THE PATIENT WAS TREATED WITH INTRA-ARTICULAR CLEANSING AND ANTIBIOTICS FOR 6 MONTHS BUT SINCE THERE WAS NO IMPROVEMENT, ALL THE DEVICES WERE REMOVED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 6432097 ↗
• InjuryJan 26, 2017Disassembly; Disassembly

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY DUE TO THE DISSOCIATION IN VIVO BETWEEN THE METAPHYSIS AND THE STEM.

  Patient problems: Failure of Implant

  MAUDE report 6279538 ↗
• InjuryJan 26, 2017Disassembly; Disassembly

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY DUE TO THE DISSOCIATION IN VIVO BETWEEN THE METAPHYSIS AND THE STEM.

  Patient problems: Failure of Implant

  MAUDE report 6279533 ↗
• InjurySep 28, 2016Break; Break

  PATIENT ORIGINALLY RECEIVED AN AEQUALIS REVERSED SHOULDER ON (B)(6) 2009. PATIENT RECENTLY PRESENTED WITH SHOULDER PAIN AND LOSS OF MOBILITY. UPON X-RAY EXAMINATION ON (B)(6) 2016, IT WAS REVEALED THAT THE METAPHYSIS HAD COMPLETELY DISSOCIATED FROM THE HUMERAL STEM. FAILED DEVICE WAS REMOVED FROM PATIENT ON (B)(6) 2016.

  Patient problems: Failure of Implant; Pain

  MAUDE report 5982943 ↗