PERFORM™ HUMERAL SYSTEM DWT4366Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00846832078615), received between Jul 16, 2024 and Dec 12, 2024 — classified as 2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "SUBJECT: (B)(6) PHS 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 20913212 ↗
• 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 19755937 ↗