TORNIER PERFORM™ HUMERAL SYSTEM DWN4316Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00846832084173), received between Nov 8, 2024 and Jun 19, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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.

• InjuryJun 19, 2026Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT SUSTAINED A PROXIMAL HUMERUS FRACTURE THAT WAS TREATED WITH TUBEROSITY REPAIR AND HEMIARTHROPLASTY. AT THE TIME OF THE PROCEDURE, THE ROTATOR CUFF WAS CONFIRMED TO BE INTACT. FOLLOWING SURGERY, THE PATIENT WAS REPORTEDLY NON-COMPLIANT WITH SLING USE AND NON-WEIGHT-BEARING RESTRICTIONS, RESULTING IN FAILURE OF THE FRACTURE REPAIR. THE PATIENT DID NOT RETURN FOR FOLLOW-UP UNTIL A LATER DATE, AT WHICH TIME CONCERNS REGARDING THE OUTCOME OF THE REPAIR WERE IDENTIFIED. FOLLOWING POSITIVE CULTURE RESULTS, THE PATIENT REQUESTED REMOVAL OF THE HEMIARTHROPLASTY AND PLACEMENT OF AN ANTIBIOTIC SPACER. THE SURGEON EXPLAINED THE ANTICIPATED FUNCTIONAL LIMITATIONS ASSOCIATED WITH REMOVAL OF THE IMPLANT; HOWEVER, THE PATIENT ELECTED TO PROCEED WITH EXPLANTATION. THE HEMIARTHROPLASTY WAS REMOVED AND REPLACED WITH AN ANTIBIOTIC SPACER.

  Patient problems: Loss of Range of Motion; Post Operative Wound Infection

  MAUDE report 25563777 ↗
• 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 23642311 ↗
• 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 23536483 ↗
• InjuryNov 8, 2024Osseointegration Problem; Osseointegration Problem

  AS REPORTED: "SUBJECT: 008-037 PHS STUDY EARLY FAILURE OF THE ANATOMICAL PROSTHESIS: THE PARTICIPANT EXPERIENCED AN EARLY FAILURE OF THE ANATOMICAL PROSTHESIS. X-RAYS OF THE LEFT SHOULDER (A.P., OUTLET, AXIAL) FROM 20.08.2024 REVEALED AN INCREASE IN ANTEROSUPERIOR ESCAPE, ESPECIALLY VISIBLE ON THE AXIAL IMAGES, WITH AN ACROMIOHUMERAL DISTANCE (AHD) OF APPROXIMATELY 5 MM. THE PROSTHESIS REMAINED FIRMLY IN PLACE. THE SURGEON DOES NOT YET CONFIRM THE RELATEDNESS. THE PLAN WAS TO DO A CONVERSION TO AN INVERSE PROTHESIS WITH THE STEM REMAINED. THE REVISION SURGERY (CONVERSION FROM ANATOMIC TO INVERSE PROTHESIS) WAS CONDUCTED ON 25 SEP 2024."

  Patient problems: Inadequate Osseointegration

  MAUDE report 20640358 ↗