TORNIER PERFORM™ HUMERAL SYSTEM DWP2420Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00846832084517), received between Sep 11, 2023 and Mar 19, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (1 report).

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 4 most recent of 4 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 24637294 ↗
• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT: (B)(6). SHOULDER ID STUDY. PATIENT RETURNED FOR NEW ONSET OF SHOULDER PAIN - LEFT SHOULDER. PAIN STARTED AFTER 3 MONTH FOLLOW-UP AND WAS SIGNIFICANTLY WORSE ON (B)(6) 2025. UNCLEAR DIAGNOSIS AT TIME OF VISIT AND PATIENT WILL UNDERGO CT FOR FURTHER ASSESSMENT.

  Patient problems: Pain

  MAUDE report 24198260 ↗
• InjuryOct 3, 2025Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO PATIENT'S SHOULDER BEING UNSTABLE FOR APPROXIMATELY TWO MONTHS. TISSUE CULTURES AND A FROZEN SPECIMEN WERE COLLECTED AND SHOWED NO BACTERIAL GROWTH. THE INSTABILITY AND FREQUENT DISLOCATIONS HAD RESULTED IN WEAR OF THE +0 THICKNESS POLY. POSTOPERATIVELY, THE SHOULDER WAS REDUCED AND STABLE.

  Patient problems: Insufficient Information

  MAUDE report 23213578 ↗
• InjurySep 11, 2023Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem

  THERE WAS A REVISION OF A TORNIER PRODUCT, SPECIFICALLY A PERFORM REVERSE GLENOID WITH A PERFORM HUMERAL STEM. THE BASEPLATE AND STEM WERE NOT REMOVED BUT WERE ADJUSTED BY LATERALIZING THE GLENOID SPHERE. A SPACER AND A NEW POLY COMPONENT WERE USED ON THE HUMERAL SIDE. THE REVISION WAS NECESSARY DUE TO INADEQUATE TENSIONING IN THE INITIAL PROCEDURE. AN UPDATE CONFIRMED THAT THE REVISION WAS SUCCESSFUL, AND IT INVOLVED CHANGING A STANDARD GLENOSPHERE FOR A LATERALIZED ONE AND BUILDING UP THE POLY COMPONENT ON THE HUMERAL SIDE.

  Patient problems: Joint Laxity; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17718466 ↗