TORNIER PERFORM™ HUMERAL SYSTEM DWX3PSRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00846832085460), received between Feb 15, 2023 and Mar 19, 2026 — classified as 10 injuries.

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT: (B)(6). SHOULDER ID STUDY. NARRATIVE: PATIENT CALLED THE CLINIC TO REPORT PAIN AND A POTENTIAL SHOULDER DISLOCATION. HE STATES HE RAISED HIS ARM OVERHEAD TOO QUICKLY. AFTER SEEING THE PATIENT, THE SURGEON REPORTED BEING CONCERNED FOR EITHER A DELTOID STRAIN OR ACROMIAL STRESS FRACTURE. THE SURGEON ADVISED THE PATIENT TO REST AND RETURN TO THE CLINIC IN TWO WEEKS WITH NEW IMAGES, AND SHE WILL FURTHER ASSESS HIM AT THAT TIME.

  Patient problems: Muscle/Tendon Damage; Pain

  MAUDE report 24637296 ↗
• 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 24232136 ↗
• InjurySep 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REVISION SURGERY WAS PERFORMED ON (B)(6) 2025, USING THE BLUEPRINT PLANNING FEATURE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 23175554 ↗
• InjuryMay 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PHS STUDY SUBJECT: (B)(6). DEEP INFECTION REQUIRING A MEDICAL INTERVENTION (OPENED DEBRIDEMENT AND IRRIGATION). INFECTION C. ACNES. RE-OPERATION WITHOUT IMPLANT EXTRACTION. DATE OF REOPERATION: ON (B)(6) 2025.

  Patient problems: Unspecified Infection

  MAUDE report 21948046 ↗
• InjuryMay 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PHS STUDY SUBJECT: (B)(6). DEEP INFECTION REQUIRING A MEDICAL INTERVENTION (OPENED DEBRIDEMENT AND IRRIGATION). INFECTION C. ACNES. RE-OPERATION WITHOUT IMPLANT EXTRACTION. DATE OF REOPERATION: (B)(6) 2025".

  Patient problems: Unspecified Infection

  MAUDE report 21948044 ↗
• InjuryDec 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "SUBJECT: (B)(6) STUDY. SCAPULAR FRACTURE. PT WAS DOING PLATES AND STRENGTH TRAINING WITH SUDDEN ONSET OF SEVERE LEFT SHOULDER PAIN GOING FROM SORE TO UNABLE TO RAISE LEFT ARM. PATIENT WAS DIAGNOSED WITH AN ACROMIAL FRACTURE (B)(6) 2024 AND RETURNED TO CLINIC (B)(6) 2024 WITH SHOULDER RECOVERING. ACTIONS TAKEN: REHABILITATION (BONE STIMULATOR) & TREATMENT/MEDICATION (SLING AT ALL TIMES, 3-4 WEEKS, DICLOFENAC AND TYLENOL FOR MILD TO MODERATE PAIN). AE UPDATE 14 NOV 2024: DESCRIPTION OF UPDATE: PATIENT HAS RECOVERED WELL AND CLINIC TEAM HAS ADVISED SHE CONTINUES TO TRANSITION INTO ALL ACTIVITIES AS TOLERATED WHILE USING BONE STIMULATOR FOR ANOTHER 6 WEEKS."

  Patient problems: Bone Fracture(s); Implant Pain; Loss of Range of Motion

  MAUDE report 20913439 ↗
• InjuryJul 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "ADVERSE EVENT DESCRIPTION: UNEXPECTED PAIN NOT RELATED TO SURGICAL RECOVERY.PATIENT CONTACTED CLINICAL TEAM AFTER HAVING SORENESS AND SOME MOVEMENT LIMITATION IN STUDY SHOULDER. ON 05/13, PATIENT REPORTED THE SYMPTOMS HAD SUBSIDED."

  Patient problems: Pain

  MAUDE report 19755486 ↗
• 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 18609099 ↗
• InjuryJun 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD AN INFECTION AND SMALL STITCH ABSCESS.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 17101436 ↗
• InjuryFeb 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WENT TO THE EMERGENCY DEPARTMENT WITH COMPLAINTS OF INCREASING SHORTNESS OF BREATH, CHEST PAIN, AND LOW GRADE FEVER. CHEST X-RAY AND CHEST CT ON (B)(6) 2023 POSITIVE FOR RIGHT LOWER AND MIDDLE LOBE OPACITIES SUSPICIOUS FOR PNEUMONIA. STARTED ON COURSE OF CEFTRIAXONE AND DOXYCYCLINE AND SUPPORTIVE CARE. THE PATIENT WAS DISCHARGED IN STABLE CONDITION WITHOUT FURTHER COMPLICATIONS.

  Patient problems: Chest Pain; Fever; Wheezing

  MAUDE report 16382171 ↗