TORNIER PERFORM™ HUMERAL SYSTEM DWP2390Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00846832084487), received between Jan 19, 2023 and May 29, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• 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 25337042 ↗
• InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED USING THE BLUEPRINT PLANNING FEATURE. THE PATIENT HAD PREVIOUSLY UNDERGONE A PRIMARY SHOULDER PROCEDURE INVOLVING STRYKER/TORNIER IMPLANTS. FOLLOWING THE INITIAL SURGERY, THE PATIENT DEVELOPED AN INFECTION, AND ALL IMPLANTS WERE EXPLANTED WITH PLACEMENT OF AN ANTIBIOTIC SPACER. THE REVISION PROCEDURE INVOLVED REMOVAL OF THE SPACER AND CONVERSION TO A REVERSE SHOULDER ARTHROPLASTY.

  Patient problems: Post Operative Wound Infection

  MAUDE report 23349499 ↗
• 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 23210451 ↗
• InjuryAug 21, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY PERFORMED ON THE SAME DAY AS THE ORIGINAL SURGERY DUE TO DISLOCATION IN POST-ANESTHESIA CARE.

  Patient problems: Inadequate Osseointegration; Joint Dislocation

  MAUDE report 20019673 ↗
• InjuryApr 16, 2024Material Fragmentation; Device Dislodged or Dislocated; Noise, Audible; Material Fragmentation; Device Dislodged or Dislocated; Noise, Audible

  A PATIENT UNDERWENT SURGERY FOR SHOULDER ISSUES, EXPERIENCING POPPING SENSATIONS. A SIGNIFICANT POP OCCURRED WHILE LIFTING A 50-POUND BAG OF FEED, LEADING TO THE DISCOVERY OF POLY DISSOCIATION WITH METAL FRAGMENTS VISIBLE ON X-RAY. SURGERY WAS PERFORMED TO REMOVE OLD POLY AND DEBRIS AND REPLACE IT WITH NEW POLY. POST-OP X-RAYS SHOWED FAVORABLE RESULTS. THE HOSPITAL REQUIRED THE IMPLANT TO BE TESTED BY PATHOLOGY, WITH THE PATIENT EXPECTING TO RECEIVE IT BACK IN A COUPLE OF WEEKS. NOTABLE CIRCUMSTANCES INCLUDE THE PATIENT'S ACTIVE LIFESTYLE AS A FARMER. SOME DEBRIS WAS OBSERVED INITIALLY BUT APPEARED TO HAVE BEEN SUCCESSFULLY REMOVED DURING THE PROCEDURE.

  Patient problems: Joint Dislocation

  MAUDE report 19120377 ↗
• 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 18609094 ↗
• InjurySep 12, 2023Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  THE PATIENT EXPERIENCED CHRONIC DISLOCATION AND INSTABILITY, LEADING TO TWO REVISION SURGERIES.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 17730899 ↗
• InjuryJul 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD A SCAPULAR FRACTURE. PATIENT EXPERIENCED SHOULDER PAIN. PATIENT CONTACTED SURGEON AND WAS INSTRUCTED TO GO TO ER FOR X-RAYS. NO FRACTURE READILY EVIDENT. PATIENT RETURNED TO CLINIC FOR SOC AND STUDY VISIT. RADIOGRAPHS CLEARLY SHOWED ACROMIAL STRESS FRACTURE WITHOUT ANGULATION NOR DISPLACEMENT OF THE FRACTURE. THE ACROMIAL STRESS FRACTURE IS HEALING WELL.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 17305107 ↗
• InjuryJan 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT WAS SEEN ON FOR STANDARD OF CARE FOLLOW-UP VISIT. THE TREATING SURGEON DID NOT FEEL A STRONG CONTRACTION IN THE AXILLARY NERVE. PATIENT COULD NOT HOLD ARM IN ABDUCTION AGAINST GRAVITY. DELTOID CONTRACTION WAS MINIMAL. PATIENT WILL COMPLETE NORMAL PHYSICAL THERAPY PLAN.

  Patient problems: Loss of Range of Motion; Muscle Weakness/Atrophy; Nerve Damage; Paralysis

  MAUDE report 16210841 ↗