TORNIER PERFORM™ HUMERAL SYSTEM DWX3SSRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00846832085477), received between Nov 12, 2021 and Jan 28, 2026 — classified as 13 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• 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 24198259 ↗
• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT: (B)(6). SHOULDER ID STUDY. SCAPULAR FRACTURE, ACROMIAL. PT BEGAN EXPERIENCING SEVERE LEFT SHOULDER PAIN STARTING AROUND (B)(6) 2025. CT COMPLETED ON (B)(6) 2025 SHOWED MINIMALLY DISPLACED FRACTURE OF THE ACROMION.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 23642357 ↗
• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT: (B)(6) SHOULDER ID STUDY (B)(6) 2025. POST-OPERATIVE ADVERSE EVENT: SCAPULAR NOTCHING. NARRATIVE: PATIENT WAS FOUND TO HAVE A LOOSE HUMERAL COMPONENT IN THE SETTING OF EARLY SCAPULAR NOTCHING AT AN UNSCHEDULED VISIT 1.5 YEARS AFTER SURGERY.

  Patient problems: Joint Impingement; Joint Laxity

  MAUDE report 23525656 ↗
• InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED USING THE BLUEPRINT PLANNING FEATURE. THE PATIENT HAD PREVIOUSLY UNDERGONE A PRIMARY SHOULDER PROCEDURE INVOLVING STRYKER/TORNIER IMPLANTS. FOLLOWING THE INITIAL SURGERY, THE PATIENT DEVELOPED AN INFECTION, AND ALL IMPLANTS WERE EXPLANTED WITH PLACEMENT OF AN ANTIBIOTIC SPACER. THE REVISION PROCEDURE INVOLVED REMOVAL OF THE SPACER AND CONVERSION TO A REVERSE SHOULDER ARTHROPLASTY.

  Patient problems: Post Operative Wound Infection

  MAUDE report 23349146 ↗
• InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INFECTION AFTER SHOULDER REPLACEMENT SURGERY. PAIN WAS ALSO REPORTED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 22795117 ↗
• InjuryJul 21, 2025Inadequacy of Device Shape and/or Size; Unstable; Device Dislodged or Dislocated; Inadequacy of Device Shape and/or Size; Unstable; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A REVISION REVERSE TOTAL SHOULDER ARTHROPLASTY WAS PERFORMED FOLLOWING A PATIENT DISLOCATION. THE SURGEON DETERMINED A TALLER INSERT WAS REQUIRED TO ADDRESS THE INSTABILITY. DURING REMOVAL OF THE EXISTING INSERT, THE HUMERAL STEM BECAME LOOSE. CONSEQUENTLY, THE SURGEON ELECTED TO REVISE BOTH COMPONENTS, IMPLANTING LARGER PERFORM REVERSE SHOULDER IMPLANTS TO RESTORE STABILITY AND FIXATION.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 22560914 ↗
• InjuryApr 9, 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 21803175 ↗
• InjuryFeb 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "SUBJECT: (B)(6) SHOULDER ID STUDY. SENSORY AND/OR MOTOR DISTURBANCE - BRANCH NEUROPATHY. PT REPORTED THAT 2 WEEKS POST-OPERATION, HE BEGAN EXPERIENCING NUMBNESS IN HIS RIGHT RING AND PINKY FINGERS."

  Patient problems: Numbness

  MAUDE report 21488522 ↗
• InjuryOct 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: SUBJECT: 08-003 PHS STEMLESS STUDY UNEXPECTED PAIN. SHE REPORTS THAT SHE HAS STARTED TO NOTICE SOME PAIN AND DISCOMFORT WITH DAILY ACTIVITIES LIKE REACHING BEHIND HER FOR HYGIENE. SHE ALSO REPORTS PAIN WHEN RAISING HER ARM OVERHEAD. SHE IS UNABLE TO USE HER RIGHT ARM TO LIFT ANYTHING. CT WAS ORDERED AND RESULTS WERE REVIEWED WITH THE SUBJECT. CT RESULTS: BONY REMODELING ALONG THE ANTERIOR PROXIMAL HUMERUS. NO EVIDENCE OF GROSS LOOSENING. MINIMAL DEGENERATIVE CHANGES OF THE ACROMIOCLAVICULAR JOINT. PROMINENT ANTEROSUPERIOR GLENOID OSTEOPHYTE FORMATION ADJACENT TO THE PERIPHERAL MARGIN OF THE GLENOSPHERE. SURGICAL CLIPS NOTED WITHIN THE RIGHT AXILLARY REGION WITHOUT LYMPHADENOPATHY. VISUALIZED RIGHT LUNG FIELD DEMONSTRATES SCATTERED GROUNDGLASS OPACITIES IN THE UPPER LOBE ANTERIORLY. ATHEROSCLEROTIC VASCULAR CALCIFICATIONS. NO JOINT EFFUSION OR PERIARTICULAR FLUID COLLECTION. NO EVIDENCE FOR ACROMIAL STRESS FRACTURE. ".

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

  MAUDE report 20393633 ↗
• InjuryAug 21, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY PERFORMED ON THE SAME DAY AS THE ORIGINAL SURGERY DUE TO DISLOCATION IN POST-ANESTHESIA CARE.

  Patient problems: Inadequate Osseointegration; Joint Dislocation

  MAUDE report 20022546 ↗
• InjuryFeb 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS HAVING BILATERAL INCISION PAIN. THERE ARE NO HARDWARE COMPLICATIONS. X-RAYS AT 12 MONTHS CONFIRMED NO HARDWARE COMPLICATION. PLAN TO WORK UP FOR INFLAMMATORY ISSUES, REFERRAL TO RHEUMATOLOGY, PAIN CLINIC AND MRI OF CERVICAL SPINE TO RULE OUT RADICULOPATHY.

  Patient problems: Pain

  MAUDE report 18681633 ↗
• InjuryOct 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS COMPLEX REGIONAL PAIN SYNDROME. PATIENT STARTED EXPERIENCING SYMPTOMS 2 WEEKS POST OPERATIVELY. PATIENT HAS BEEN GOING TO PHYSIO THERAPY TO MANAGE SYMPTOMS. EVENT IS ONGOING.

  Patient problems: Implant Pain

  MAUDE report 18012046 ↗
• InjuryJun 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SUPERFICIAL INFECTION. THE PHYSICIAN TREATED THE INFECTION WITH IRRIGATION AND DEBRIDEMENT WITH SALINE AND VANCOMYCIN POWDER. ALL THE HARDWARE WAS LEFT IN THE PATIENT AS THE DOCTOR DEEMED THE INFECTION WAS NOT DEEP ENOUGH TO HAVE BEEN A RESULT OF THE IMPLANTS. THE PATIENT WAS ADMINISTERED AND PRESCRIBED ANTIBIOTICS.

  Patient problems: Unspecified Infection

  MAUDE report 17233809 ↗
• MalfunctionNov 12, 2021Difficult to Insert; Difficult to Insert

  THE SURGEON IMPLANTED THE PERFORM HUMERAL #3 STANDARD STEM IN THE PATIENT AND WHILE ATTEMPTING TO IMPACT THE 39MM + 6 REVERSE INSERT HE COULDN¿T SUCCESSFULLY SEAT IT INTO THE STEM. AFTER SEVERAL ATTEMPTS IT WAS DECIDED TO OPEN A SECOND REVERSE INSERT. PRIOR TO ATTEMPTING TO IMPLANT THE SECOND REVERSE INSERT THE HUMERAL CUT SURFACE WAS INSPECTED, TRIMMED & REAMED TO ASSURE THAT THERE WAS NOTHING BLOCKING THE INSERT TO SEAT CORRECTLY. ON THE SECOND REVERSE IMPLANT ATTEMPT THE SURGEON EXPERIENCED THE SAME ISSUES AND ENDED UP DROPPING THE SECOND IMPLANT TO THE FLOOR. THE SURGEON THEN EXPLANTED THE PERFORM HUMERAL STEM AND ATTEMPTED SEVERAL TIMES TO IMPACT THE REVERSE INSERT THAT WAS OPENED THE FIRST TIME ON THE BACK TABLE WITH THE IMPACTION STAND WITHOUT SUCCESS. AT THAT TIME, HE ASKED FOR A NEW PERFORM HUMERAL STEM TO BE OPENED AND REVERSE INSERT. THE NEW PERFORM HUMERAL STEM AND INSERT WAS IMPLANTED WITHOUT ANY PROBLEMS. THIS WHOLE TROUBLESHOOTING PROCESS PROBABLY ADDED 20-30 MINUTES TO THE SURGICAL TIME. NO COMPLEMENTARY ANESTHESIA WAS GIVEN. NO BONE LOSS WAS EXPERIENCED DUE TO THESE COMPLICATIONS. PERFORM HUMERAL CORE TRAY AND PERFORM HUMERAL STEM TRAY WAS USED FOR THIS SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12801932 ↗