TORNIER PERFORM™ HUMERAL SYSTEM DWX2PSRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00846832085422), received between Jan 5, 2022 and Dec 18, 2025 — classified as 12 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT: (B)(6). SHOULDER ID STUDY. THE PATIENT CALLED THE UTSW ORTHOPAEDIC SURGERY CLINIC IN FRISCO (B)(6) 2025 TO REPORT HE "ACCIDENTALLY PICKED UP A GALLON CONTAINER AND HELD IT FOR ABOUT 2 MINUTES". HE REPORTED INCREASING PAIN IN HIS LEFT SHOULDER WITH MOVEMENT. HE SAID HE FELT AS IF HE WAS "BACK TO SQUARE 1" AS PRIOR TO THE SHOULDER SURGERY. THE SURGEON ORDERED X-RAYS 13/NOV/2025 AND DETERMINED THEY "LOOKED GOOD" AND SHE ADVISED THE PATIENT TO REST THE SHOULDER.

  Patient problems: Pain

  MAUDE report 23838739 ↗
• InjuryNov 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT: (B)(6) SHOULDER ID STUDY. INFECTION - DEEP. SUBJECT WAS FOUND TO HAVE GLENOID BASEPLATE LOOSENING AND INFECTION AT UNSCHEDULED 6-MONTH POST-OPERATIVE VISIT.

  Patient problems: Unspecified Infection

  MAUDE report 23665745 ↗
• 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 23536168 ↗
• InjuryMay 13, 2025Osseointegration Problem; Migration; Osseointegration Problem; Migration

  IT WAS REPORTED BY THE CUSTOMER THAT PATIENT HAD A REVERSE FOR ROTATOR CUFF DEFICIENCY. HER SHORT UNCEMENTED STEM SUBSIDED AND LOOSENED BY 4-5MM. I AM PLANNING ON REVISING TO A LARGER POLY OR A SPACER IF THE STEM IS SOLID OR REVISING THE STEM TO A STANDARD LENGTH AND CEMENTING IT. I THINK THE GLENOSPHERE/BASEPLATE IS SOLID, BUT TOUGH TO TELL. SHE WAS ONLY OPERATED ON (B)(6) 2024.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22012506 ↗
• InjuryApr 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "SUBJECT: (B)(6). SCAPULAR FRACTURE UPDATE ON 10 MAR 2025: O NO ACTION TAKEN O SITE REPORTS: SURGERY WAS DISCUSSED BUT DECIDED AGAINST".

  Patient problems: Bone Fracture(s)

  MAUDE report 21760722 ↗
• InjuryFeb 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PHS STEMLESS IDE: (B)(6). UNEXPECTED PAIN. SUBJECT'S DOG PULLED SURGICAL ARM ON A WALK CAUSING NUMBNESS, LIMP RIGHT ARM, AND PAIN. BRUISING ON FRONT OF ARM. NUMBNESS AND TINGLING AND WEAKNESS OF ARM IMPROVED WITH REST, BUT REPORTS FEELING TIGHTNESS WITH MOVEMENT. PT REFERRAL PLACED. HAS ONLY ATTENDED ONE PT TREATMENT AS OF REPORT DATE. REPORTS ONGOING PAIN AND STIFFNESS."

  Patient problems: Implant Pain; Loss of Range of Motion; Numbness

  MAUDE report 21456854 ↗
• InjuryJan 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "SUBJECT: 004-015 SHOULDER ID STUDY PT BEGAN EXPERIENCING CONSTANT SEVERE SHOULDER PAIN ON (B)(6) 2024. CT UNREMARKABLE. AS OF (B)(6) 2024. PATIENT STILL IS EXPERIENCING SHOULDER PAIN, BUT NO LONGER AS CONSTANT OR SEVERE.".

  Patient problems: Implant Pain

  MAUDE report 21262256 ↗
• InjuryNov 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PHS STUDY SUBJECT: (B)(6). 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 20683135 ↗
• InjuryOct 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PHS STUDY SUBJECT: (B)(6). PATIENT PRESENTED WITH SEVERE PAIN IN LEFT SHOULDER ON (B)(6) 2024. ADMITTED SEEN BY ORTHOPAEDIC SURGEON X-RAY ON (B)(6) 2024 SHOWED MILDLY DISPLACED EXTRA ARTICULAR TRANSVERSE FRACTURE LEFT ACROMION. CT SCAN (B)(6) 2024. REPEAT X-RAYS ON (B)(6) 2024. REPEAT CT ON (B)(6) 2024. PATIENT HAD SLING REMOVED 3 WEEKS AGO, CONTINUING WITH PHYSIO."

  Patient problems: Implant Pain; Malunion of Bone

  MAUDE report 20426052 ↗
• InjuryJul 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT REQUIRED REVISION SURGERY AS THERE WAS TEARING OF THE GLENOID DUE TO SEPSIS.

  Patient problems: Sepsis

  MAUDE report 19697176 ↗
• InjuryMar 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING EVENTS WERE REPORTED BY THE CLINICAL STUDY SITE: "ON (B)(6) 2023: SUBJECT PRESENTED TO ED WITH FEVER AND WORSENED CONFUSION. REPORTED FEVER OF 102 F ON (B)(6) 2023 ALONG WITH POOR ORAL INTAKE, DIZZINESS AND SLIGHT INCREASE IN URINARY FREQUENCY. DENIED CHILLS, COUGH, SHORTNESS OF BREATH, DIARRHEA AND BURNING WITH URINATION. ON (B)(6) 2023: SUBJECT REPORTING TO FEEL BETTER AND ACKNOWLEDGES SOME GAPS IN MEMORY. DENIES ANY SHORTNESS OF BREATH OR CHEST PAIN. NOW ON ROOM AIR. KIDNEY FUNCTION IMPROVED AND LABS WITHIN NORMAL LIMITS. URINE CULTURE PRELIMINARY RESULTS GROWING E. COLI. NO EPISODES OF FEVER SINCE ADMISSION. WBC WNL. IV CEFTRIAXONE CHANGED TO 2 GRAMS DAILY. ON (B)(6) 2023: NO ACUTE EVENTS OVERNIGHT. SUBJECT CONTINUES TO FEEL BETTER. DENIES ANY SHORTNESS OF BREATH OR CHEST PAIN. FINAL RESULT FOR URINE CULTURE GROWING E. COLI. PRELIMINARY BLOOD CULTURE RESULTS GROWING E. COLI. REPEAT BLOOD CULTURES DRAWN. ON (B)(6) 2023: NO ACUTE EVENTS OVERNIGHT. DENIES ANY SHORTNESS OF BREATH OR CHEST PAIN. CONTINUES TO IMPROVE CLINICALLY. CONTINUE IV CEFTRIAXONE 2 GRAMS DAILY. ID CONSULTED AND RECOMMENDED RENAL ULTRASOUND TO RULE OUT ABSCESS OR INFECTIOUS COLLECTION OF THE KIDNEY

  Patient problems: Bacteremia; Confusion/ Disorientation; Dizziness; Fever; Urinary Frequency / Polyuria

  MAUDE report 16629921 ↗
• InjuryJan 5, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE POLY BECAME DISASSOCIATED WITH THE STEM. WE REVISED THE PATIENT, IMPLANTING A NEW STEM SPACER, AND NEW POLY.

  Patient problems: Failure of Implant

  MAUDE report 13169541 ↗