TORNIER PERFORM™ HUMERAL SYSTEM DWT110Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00846832085095), received between Nov 14, 2024 and Nov 25, 2025 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT: (B)(6). PERFORM HUMERAL SYSTEM STUDY (PHS). UNEXPECTED PAIN NOT RELATED TO SURGICAL RECOVERY. SUBJECT CONTACTED SURGEON'S OFFICE WITH COMPLAINTS OF PAIN. SUBJECT COMPLETED A COURSE OF PHYSICAL THERAPY AND UNDERWENT AN ULTRASOUND WHICH SHOWED MILD BURSITIS. SUBJECT WAS STILL EXPERIENCING PAIN AT TWO-YEAR POST-OP VISIT AND RECEIVED A STEROID INJECTION.

  Patient problems: Implant Pain

  MAUDE report 23642309 ↗
• InjuryNov 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT: (B)(6) PERFORM HUMERAL SYSTEM (PHS) STUDY. POST-OPERATIVE ADVERSE EVENT: BILATERAL PULMONARY EMBOLISM (PE) ADVERSE EVENT DESCRIPTION: SOB (SHORTNESS OF BREATH) FOR 3 WEEKS, D-DIMER 21536. STUDY DEVICE: NOT RELATED. SURGICAL PROCEDURE: CAUSAL RELATIONSHIP. IS THIS A SERIOUS ADVERSE EVENT (SAE)? : YES. MEDICATION: DALTEPARIN, CTPA, APIXABAN.

  Patient problems: Pulmonary Embolism

  MAUDE report 23536644 ↗
• InjuryApr 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "SUBJECT:(B)(6). PHS STUDY. PAINFUL ORTHOPAEDIC HARDWARE. REOPERATION WITHOUT IMPLANT EXTRACTION (B)(6) 2024) L SHOULDER OPEN DEEP HARDWARE REMOVAL."

  Patient problems: Pain

  MAUDE report 21836763 ↗
• InjuryJan 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "SUBJECT: (B)(6). ON (B)(6) 2024- RIGHT SHOULDER ANTERIOR BASED PAIN FROM CERCLAGE WIRES (B)(6) 2024- INTERMITTENT PAIN AND CATCHING/STABBING PAIN 2-4+ TIMES A DAY. PATIENT REQUIRED REVISION SURGERY."

  Patient problems: Implant Pain

  MAUDE report 21252552 ↗
• InjuryNov 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PHS STUDY SUBJECT: (B)(4). COMPLICATION DESCRIPTION: BROKEN CERCLAGE AND HARDWARE REMOVAL. AE DESCRIPTION (INCLUDING TEST, RESULTS): PATIENT X-RAYS ON (B)(6) 2024 SHOWED INTACT HARDWARE AND OSTEOTOMY WITH BROKEN CERCLAGE WIRE. PATIENT UNDERWENT SX (B)(6) 2024 TO REMOVE PAINFUL HARDWARE."

  Patient problems: Implant Pain

  MAUDE report 20680703 ↗