Tornier Perform® Reversed Glenoid DWJ013Recalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 00846832090341), received between Jan 19, 2023 and Jul 15, 2026 — classified as 57 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Unstable” (16 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 60 reports, in the reporter's own words as published by the FDA.

• InjuryJul 15, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT A RIGHT REVERSE SHOULDER REPLACEMENT SURGERY. WEEKS LATER, THE WOUND OVER THE SURGICAL SITE WAS OOZING FLUID, BECAME RED AND INFLAMED, AND WAS PAINFUL. CULTURE OF THE SURGICAL SITE IDENTIFIED C. ACNES BACTERIAL INFECTION. DURING THE REVISION PROCEDURE, THE SURGEON COLLECTED ADDITIONAL SPECIMENS FOR PATHOLOGY, PERFORMED DEBRIDEMENT, LAVAGED THE SURGICAL SITE, AND FINALLY REPLACED THE IMPLANTS.

  Patient problems: Bacterial Infection; Erythema; Inflammation; Pain

  MAUDE report 25830231 ↗
• InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "BECAUSE THE PATIENT WAS EXPERIENCING PAIN, A REVISION SURGERY WAS PERFORMED TO DETERMINE IF THE IMPLANT WAS LOOSE OR NEEDED RESIZING. A SLIGHT FOREIGN BODY REACTION SUGGESTIVE OF INFECTION WAS OBSERVED."

  Patient problems: Pain; Unspecified Infection

  MAUDE report 25337188 ↗
• InjuryApr 2, 2026Osseointegration Problem

  IT WAS REPORTED THAT, IN (B)(6) 2024 THE PRIMARY IMPLANTATION OF TORNIER FLEX COMPONENTS / PERFORM REVERSED COMPONENTS WAS DONE. THE INDICATION FOR WHICH THE IMPLANT WAS INITIALLY USED WAS NOT A FRACTURE, DEGENERATIVE ARTHROSIS. ON (B)(6) 2026, THE REVISION SURGERY WAS DONE DUE TO GLENOID BONE EROSION. THE IMPLANT WAS PROPERLY SET, BUT THE BONE QUALITY WAS REALLY POOR AND THE IMPLANT STARTED LOOSENING EARLY WITH THE BONE INTEGRATION. THE REVISION SURGERY FACED A HUGE BONE LOSS SURGICAL DELAY OF 15 MINUTES TO MANAGE VEIN BLEEDING AND VEIN BLEEDING WAS MANAGED PROPERLY, NO ADVERSE CONSEQUENCES. PROCEDURE WAS COMPLETED SUCCESSFULLY. THE FINAL IMPLANT WAS A HEMIARTHROPLASTY WITH GLENOID BONE GRAFT, INSTEAD OF A RE-IMPLANT WITH A REVERSED IMPLANT IN THE GLENOID.

  Patient problems: Inadequate Osseointegration; Osteolysis

  MAUDE report 24763390 ↗
• InjuryMar 3, 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 24494260 ↗
• InjuryFeb 24, 2026Unstable

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES PERFORMED BETWEEN MARCH 2023 - SEPTEMBER 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024 A PATIENT REQUIRED REVISION SURGERY DUE TO INSTABILITY, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Joint Laxity

  MAUDE report 24428215 ↗
• InjuryFeb 19, 2026Unstable

  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 INSTABILITY, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Joint Laxity

  MAUDE report 24387420 ↗
• InjuryFeb 16, 2026Unstable

  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 INSTABILITY, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Joint Laxity

  MAUDE report 24342750 ↗
• InjuryFeb 13, 2026Unstable

  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 IN 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024 A PATIENT REQUIRED REVISION SURGERY DUE TO INSTABILITY, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Joint Laxity

  MAUDE report 24331350 ↗
• InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT: (B)(6). (B)(4) STUDY. REPLACEMENT OF THE COMPLETE PROSTHESIS DUE TO CHRONIC LOW-GRADE INFECTION. (LEUKOCYTES 8. G/L, CRP 17.7 MG/L, CELL COUNT: 12,300, 98% POLYNUCLEAR: MIBI FROM PUNCTURE: RENEWED DETECTION OF CUTIBACTERIUM ACNES IN THE CULTURE, PENICILLIN-SENSITIVE)

  Patient problems: Unspecified Infection

  MAUDE report 24232014 ↗
• InjuryJan 26, 2026Unstable

  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 INSTABILITY, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Joint Laxity

  MAUDE report 24176412 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE PATIENT UNDERWENT LEFT REVERSE SHOULDER REPLACEMENT ON (B)(6) 2025. PT EXPERIENCED A VERY POSITIVE POST-OP REHAB / RECOVERY, DEMONSTRATING (ACCORDING TO THE SURGEON) A FULL RANGE OF MOTION OF HIS PROSTHETIC SHOULDER JOINT, WITHIN 6 WEEKS POST-OP. LATER, PATIENT WAS RIDING A PUSH BIKE (IN THE EARLY HOURS OF THE MORNING), AND FELL OFF, DISLOCATING HIS LEFT SHOULDER JOINT. UNABLE TO BE CLOSED REDUCED. SURGEON DECIDED ON A MUA, BOOKED FOR (B)(6) 2025. JOINT REDUCED, UNDER ANESTHESIA, BUT GROSSLY UNSTABLE. SURGEON DECIDED ON AN OPEN PROCEDURE. TORNIER FLEX REVERSED 0MM TRAY WAS REMOVED, ALONG WITH THE TORNIER REVERSED INSERT 39MM/9MM, AND A THICKER TRAY (6MM) AND (SAME SIZE) NEW INSERT WERE IMPLANTED. ON REDUCTION, THE JOINT WAS STILL UNSTABLE. SURGEON DISLOCATED THE JOINT, REMOVED THE NEW REVERSE TRAY / POLY INSERT, AND PROCEEDED TO EXPLORE FOR FURTHER CAUSES OF THE IMPINGEMENT / INSTABILITY. MORE POSTERO-INFERIOR GLENOID BONE WAS REMOVED. THE (PRIMARY) IMPLANTED 39MM STANDARD GLENOSPHERE WAS THEN REMOVED, REPLACED BY A 42MM STANDARD GLENOSPHERE. THE SUPERIOR GLENOID 30MM SCREW WAS FOUND TO BE LOOSE, AND REPLACED WITH A 34MM SCREW. A NEW 12MM FLEX REVERSE TRAY

  Patient problems: Fall; Subluxation

  MAUDE report 24066672 ↗
• InjuryJan 13, 2026Unstable

  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, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Joint Laxity

  MAUDE report 24054624 ↗
• InjuryJan 5, 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) 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 23958142 ↗
• InjuryJan 5, 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 WITH THE TORNIER SHOULDER SYSTEM. THE REPORT DETAILS ANALYSIS PROVIDED FOR 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. REVISION PROCEDURE TYPE: STAGE 1 OF 2 STAGE REVISION.

  Patient problems: Unspecified Infection

  MAUDE report 23957280 ↗
• InjuryDec 24, 2025Unstable; 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 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 INSTABILITY, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. REVISION PROCEDURE TYPE: SINGLE STAGE REVISION (INCLUDES DAIR WITH MODULAR EXCHANGE AND MODULAR EXCHANGE FOR INDICATIONS OTHER THAN INFECTION).

  Patient problems: Joint Laxity

  MAUDE report 23886853 ↗
• InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT: (B)(6) SHOULDER ID STUDY. THE PATIENT CALLED THE (B)(6) CLINIC IN (B)(6) 2025 TO REPORT HE "ACCIDENTALLY PICKED UP A GALLON CONTAINER AND HELD IT FOR ABOUT 2 MINUTES." HE REPORTED INCREASING PAIN IN HIS LEFT SHOULDER WITH MOVEMENT. HE SAID HE FELT AS IF HE WAS "BACK TO SQUARE 1" AS PRIOR TO THE SHOULDER SURGERY. THE SURGEON ORDERED X-RAYS (B)(6) 2025 AND DETERMINED THEY "LOOKED GOOD" AND SHE ADVISED THE PATIENT TO REST THE SHOULDER.

  Patient problems: Pain

  MAUDE report 23838741 ↗
• InjuryDec 1, 2025Unstable; Unstable

  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 IN 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024 A PATIENT REQUIRED REVISION SURGERY DUE TO INSTABILITY, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Joint Laxity

  MAUDE report 23687194 ↗
• InjuryDec 1, 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 IN 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 23687100 ↗
• InjuryDec 1, 2025Unstable; Unstable

  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, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Joint Laxity

  MAUDE report 23686307 ↗
• InjuryNov 26, 2025Unstable; Unstable

  SUBJECT: (B)(6) PERFORM FRACTURE STUDY. INSTABILITY ¿ DYNAMIC. SUBJECT CONTACTED CLINIC ON (B)(6) 2025 WITH REPORTS OF ATRAUMATIC INSTABILITY AND PAIN. SHE WAS SEEN IN CLINIC ON (B)(6) 2025. X-RAYS AND CT SCAN SHOWED MILD NOTCHING BUT NO OTHER ABNORMALITIES. NO DOCUMENTED DISLOCATIONS.

  Patient problems: Joint Impingement; Pain

  MAUDE report 23656592 ↗
• InjuryOct 20, 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 23334527 ↗
• InjuryOct 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT; REVISION SURGERY WAS PERFORMED ON PATIENT FOR POSTOPERATIVE SUBCUTANEOUS INFECTION. THERE IS A SUSPICION OF INFECTION WITH ACNE BACTERIA, AND TESTS ARE CURRENTLY BEING CONDUCTED. NO FURTHER INFORMATION WAS PERFORMED.

  Patient problems: Unspecified Infection

  MAUDE report 23210450 ↗
• InjurySep 9, 2025Unstable; Unstable

  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, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Joint Laxity

  MAUDE report 23001732 ↗
• InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2024. APPROXIMATELY ONE YEAR LATER, THE PATIENT VISITED THE HOSPITAL DUE TO SUSPECTED INFECTION. ALTHOUGH THE CONDITION WAS INITIALLY MANAGED WITH MEDICATION, 2ND SURGERY WAS PERFORMED ON (B)(6) 2025 TO REOPEN AND IRRIGATE THE SURGICAL SITE. DUE TO PERSISTENT INFECTION, A 3RD SURGERY WAS PERFORMED ON (B)(6) 2025. ACCORDING TO THE SURGEON, THERE WAS NO LOOSENING OF THE STEM AND BASEPLATE FIXED WITHIN THE BONE, AND NO SIGNS OF INTRAMEDULLARY INFECTION. THEREFORE, ONLY THE EXTERNAL IMPLANT COMPONENTS¿THE INSERT AND SPHERE¿WERE REMOVED. THE WOUND WAS THOROUGHLY IRRIGATED USING A BRUSH, AND NEW IMPLANTS OF THE SAME SIZE WERE REINSERTED BEFORE CLOSING THE SURGICAL SITE. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 22795556 ↗
• InjuryJul 9, 2025Unstable; Unstable

  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 & INSTABILITY, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. STAGE 1 OF 2 STAGE REVISION.

  Patient problems: Joint Laxity; Unspecified Infection

  MAUDE report 22456108 ↗