Tornier Perform® Reversed Glenoid DWJ023Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00846832090389), received between Jan 10, 2022 and Sep 29, 2026 — classified as 16 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 18, 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.

• InjurySep 29, 2026Unstable

  As reported: "Patients shoulder became unstable six months after initial RSA surgery so surgeon performed a revision surgery to exchange the 39mm Glenosphere and 45% reverse poly insert."

  Patient problems: Joint Laxity

  MAUDE report 50934359 ↗
• InjuryMay 20, 2026Adverse 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES OF MONTHLY REPORT OF (B)(6) 2026 DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2026, A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 25229450 ↗
• InjuryFeb 16, 2026Adverse 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES PERFORMED UNTIL (B)(6) 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 24342152 ↗
• InjuryDec 10, 2025Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES PERFORMED UNTIL (B)(6) 2025. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2025 A PATIENT REQUIRED REVISION SURGERY DUE TO INSTABILITY, DISLOCATION & SUBLUXATION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Joint Laxity; Subluxation

  MAUDE report 23768660 ↗
• InjuryMay 26, 2025Adverse 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 OF THE SHOULDER JOINT REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES PERFORMED UNTIL (B)(6) 2025. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2025 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 22083417 ↗
• InjuryNov 28, 2024Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  AS REPORTED: "SUBJECT (B)(6) SHOUT - TORNIER SHOULDER OUTCOMES STUDY. RECENTLY UNDERWENT REVISION REVERSE WITH AN ALLOGRAFT PROSTHESIS AND SUBSEQUENTLY HAD A DISLOCATION. ON (B)(6) 2022 : INSERT, TRAY AND GLENOSPHERE WERE REPLACED DURING REVISION SURGERY DUE TO INSTABILITY- DISLOCATION. INSERT: 39 DIA RETENTIVE +9MM/7.5C. TRAY: CENTERED +0MM. GLENOSPHERE: 39MM LATERALIZED (+3MM))".

  Patient problems: Joint Laxity; Subluxation

  MAUDE report 20804615 ↗
• InjurySep 5, 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. REVISION PROCEDURE TYPE: DEBRIDEMENT AND IMPLANT RETENTION (DAIR).

  Patient problems: Unspecified Infection

  MAUDE report 20144282 ↗
• InjuryJul 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A REVISION SURGERY DUE TO CONVERSION FROM AN ANATOMIC TO A REVERSE SHOULDER CONFIGURATION, DURING WHICH A GREATER TUBEROSITY FRACTURE OCCURRED. THE SURGEON PLANNED A TWO-STAGED REVISION: THE FIRST STAGE INVOLVED REMOVING ALL IMPLANTS AND PLACING A REVERSE GLENOID; THE SECOND STAGE INCLUDED REPLACING THE GLENOID SPHERE AND IMPLANTING THE HUMERAL STEM.

  Patient problems: Limb Fracture

  MAUDE report 19774564 ↗
• InjuryMar 22, 2024Biocompatibility; Biocompatibility

  THE PATIENT REPORTED PAIN AND DECREASED FUNCTION, LEADING TO A REVISION SURGERY. THE REASON FOR THE REVISION SURGERY WAS LISTED AS HETEROTOPIC OSSIFICATION, SEVERE STIFFNESS, AND NICKEL METAL ALLERGY. COMPONENTS INCLUDING THE TRAY, INSERT, AND GLENOSPHERE WERE EXPLANTED, WHILE THE STEM, BASEPLATE, AND CENTRAL SCREW WERE RETAINED. THE RELATEDNESS TO THE STUDY DEVICE AND THE SURGICAL PROCEDURE WAS ASSESSED AS POSSIBLE.

  Patient problems: Extraskeletal ossification; Implant Pain; Loss of Range of Motion; Metal Related Pathology

  MAUDE report 18963882 ↗
• InjuryFeb 29, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  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 TO DISLOCATION/SUBLUXATION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. REVISION PROCEDURE TYPE: SINGLE STAGE REVISION.

  Patient problems: Joint Dislocation; Subluxation

  MAUDE report 18812567 ↗
• InjuryFeb 26, 2024Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT REQUIRED REVISION SURGERY AFTER EXPERIENCING LOOSENING OF THE GLENOSPHERE. THE GLENOSPHERE WAS REPLACED SUCCESSFULLY AND WITH GOOD OUTCOME FOR THE PATIENT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18783688 ↗
• InjuryJan 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN THE PHS STEMLESS IDE STUDY, A PARTICIPANT REPORTED STIFFNESS AND DISCOMFORT IN THE NECK AND LEFT HAND. DESPITE RECEIVING TREATMENTS LIKE MELOXICAM AND ORAL STEROIDS, THE SYMPTOMS PERSISTED. SEEKING A SECOND OPINION FROM A HAND SPECIALIST, THE PATIENT UNDERWENT A STEROID INJECTION IN THE LEFT RING AND LONG FINGERS. DISSATISFIED WITH THE PROGRESS AND CARE, THE PARTICIPANT WAS REFERRED TO ANOTHER HAND SURGEON FOR FURTHER EVALUATION, INCLUDING PENDING EMG AND CERVICAL MRI. THE PATIENT ATTRIBUTES THE SYMPTOMS TO A PREVIOUS SHOULDER SURGERY, EXPRESSING CERTAINTY THAT IT IS THE ROOT CAUSE.

  Patient problems: Discomfort; Loss of Range of Motion

  MAUDE report 18609104 ↗
• InjurySep 6, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A REVISION SURGERY, LARGER GLENOSPHERE AND POLY IMPLANTS WERE USED TO ADDRESS CHRONIC DISLOCATION IN THE PATIENT'S SHOULDER JOINT. IT'S LIKELY THAT THE TEETH OF ONE OF THE INSTRUMENTS, SPECIFICALLY THE GLENOSPHERE REMOVAL TOOL, WERE BENT PRIOR TO THE SURGERY, AS THEY WERE OBSERVED TO BE SLIGHTLY BENT FROM THE OUTSET. THE GLENOSPHERE AND POLY IMPLANTS WERE TORNIER PRODUCTS. HOWEVER, IT'S IMPORTANT TO NOTE THAT THE REVISION SURGERY WAS NOT DUE TO FAULTY IMPLANTS BUT RATHER INSTABILITY ISSUES. THE SURGICAL PROCEDURE ENCOUNTERED DIFFICULTIES INITIALLY DUE TO THE DAMAGED INSTRUMENT BUT PROCEEDED SMOOTHLY AFTER SWITCHING TO ANOTHER SET OF INSTRUMENTS.

  Patient problems: Joint Dislocation

  MAUDE report 17692120 ↗
• InjuryAug 23, 2023Osseointegration Problem; Osseointegration Problem

  THE TORNIER SHOULDER OUTCOMES STUDY'S PATIENT EXPERIENCED A REVISION SURGERY DUE TO ISSUES WITH LOOSENING/LYSIS. DURING THE PROCEDURE, A GLENOID SPHERE WAS REMOVED AND REPLACED WITH A REVERSED-LATERALIZED GLENOSPHERE THAT WAS 3MM LARGER (39MM). AN ADDITIONAL UPDATE REVEALED THAT THE TORNIER HRS ARS741701 WAS ALSO REMOVED DURING THE SURGERY.

  Patient problems: Inadequate Osseointegration; Osteolysis

  MAUDE report 17602969 ↗
• InjuryNov 1, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED AFTER PATIENT COMPLAINT AND NOTIFIED PHYSICIAN. RADIOGRAPHS WERE TAKEN AND THE PHYSICIAN STATED THE IMPLANT APPEARED TO HAVE DISASSOCIATED FROM BASEPLATE. PATIENT NOTICED A DIFFERENCE IN THE WAY HIS SHOULDER FELT AFTER 1 YEAR AFTER BEING IMPLANTED. RADIOGRAPHS ARE AVAILABLE PRE AND POST OPERATIVE, NO REMARKABLE CIRCUMSTANCES NOTED TO CONTRIBUTE TO THIS EVENT. PATIENT REQUIRED REVISION AFTER PHYSICIAN DOCUMENTED VIA RADIOGRAPHS THAT THE GLENOSPHERE APPEARED TO BECOME DISASSOCIATED FROM WELL-FIXED BASEPLATE. OTHER IMPLANTS NOTED FOR THE REVERSE SHOULDER ARTHROPLASTY WERE GLENOID BASEPLATE, X 2 SCREWS, HUMERAL CUP, POLY AND HUMERAL STEM. THE EXPLANTED IMPLANTS WERE REQUESTED TO BE RETURNED AT THE TIME OF THE REVISION SURGERY BUT HAVE NOT RECEIVED THESE BACK FROM HOSPITAL TO DATE.

  Patient problems: Failure of Implant

  MAUDE report 15712568 ↗
• InjuryJan 10, 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 TWO YEARS AFTER PRIMARY STUDY SURGERY DUE TO INFECTION. THE STEM, TRAY AND INSERT WERE REMOVED, AS WELL AS REVERSED BASEPLATE AND GLENOSPHERE. FIRST STAGE OF A 2-STAGE SURGERY: REVISED TO ANTIBIOTIC CEMENT HEMI.

  Patient problems: Unspecified Infection

  MAUDE report 13212719 ↗