TORNIER PERFORM™ HUMERAL SYSTEM DWP1360Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00846832084395), received between Aug 17, 2023 and Nov 13, 2025 — classified as 10 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A COMPETITOR'S ARTIFICIAL HUMERAL HEAD WAS IMPLANTED, BUT DUE TO DIFFICULTY WITH ELEVATION, IT WAS REPLACED WITH A STRYKER RSA. DURING THIS PROCEDURE, TO REMOVE THE COMPETITOR'S STEM, IT WAS NECESSARY TO SEPARATE THE GREATER TUBERCLE FROM THE SHAFT. SUBSEQUENTLY, THE GREATER TUBERCLE GRADUALLY FRACTURED OR RATHER, IT MIGRATED. IT WAS REPORTED THAT THE PATIENT HAD A FRACTURE OF THE GREATER TUBERCLE AROUND THE STEM. DEBRIDEMENT WAS PERFORMED ON (B)(6). BONE FRAGMENTS AND CEMENT PARTICLES WERE REMOVED. WHILE THERE WERE NO ISSUES WITH STABILITY, THE PROCEDURE CONCLUDED BY FILLING THE SLIGHT GAP BETWEEN THE STEM AND THE PROXIMAL END WITH CEMENT. BUT THEN DISLOCATION WAS FOUND, AND REVISION SURGERY WAS PERFORMED ON (B)(6) 2025.

  Patient problems: Subluxation

  MAUDE report 23550242 ↗
• InjuryJul 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED: "THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2025, AND ON (B)(6) DURING A FOLLOW-UP OUTPATIENT VISIT, THE DOCTOR CONFIRMED THAT THE PATIENT HAD A DISLOCATION. SINCE THE DISLOCATION WAS SELF-REDUCED, THE PATIENT WAS ADVISED TO WAIT AND SEE, BUT SINCE THE PATIENT REQUESTED A REOPERATION, A REOPERATION WAS SCHEDULED FOR (B)(6)."

  Patient problems: Joint Dislocation

  MAUDE report 22440558 ↗
• InjuryMar 11, 2025Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  AS REPORTED: "SUBJECT: 09-013 PHS STEMLESS IDE STUDY. POST-OPERATIVE COMPLICATION: INSTABILITY - SUBLUXATION. ENDORSES SUBLUXATION/DISLOCATION EVENT WHILE CUTTING FROZEN CHEESE. ABLE TO SELF-REDUCE. PAIN DISSIPATED WITH REDUCTION."

  Patient problems: Implant Pain; Joint Laxity; Subluxation

  MAUDE report 21574038 ↗
• 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 21456853 ↗
• InjuryJan 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "SUBJECT: (B)(6): 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 21262259 ↗
• InjurySep 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PATIENT HAD DELTOID MUSCLE DYSFUNCTION".

  Patient problems: Loss of Range of Motion

  MAUDE report 20298654 ↗
• InjuryJul 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT: (B)(6). SHOULDER ID STUDY. AS REPORTED: PATIENT REPORTED A "CATCHING" FEELING IN SHOULDER WITH INCREASED PAIN SINCE (B)(6) 2024. PT ALSO HAD A FEVER ON (B)(6) 2024; ANTIBIOTICS WERE PRESCRIBED FOR THIS. AS OF (B)(6) 2024, THE PATIENT REPORTED THAT HER SHOULDER PAIN IS IMPROVING.

  Patient problems: Fever; Implant Pain; Joint Impingement

  MAUDE report 19833652 ↗
• InjuryJun 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT A RIGHT REVERSE SHOULDER ARTHROPLASTY (RSA). A POSTOPERATIVE X-RAY REVEALED THAT THE POLYETHYLENE INSERT WAS NOT PROPERLY SEATED IN THE HUMERAL STEM. THE PATIENT UNDERWENT A REVISION RSA THE FOLLOWING DAY, WHERE A NEW REVERSE INSERT WAS IMPLANTED. ADDITIONAL FEEDBACK FROM A SALES REPRESENTATIVE CONFIRMED THAT DURING A SECOND SURGERY, IT WAS OBSERVED THAT THE POLYETHYLENE INSERT WAS NOT FULLY SEATED IN THE HUMERAL STEM. THE PATIENT WAS RETURNED TO THE OPERATING ROOM FOR A REVISION, AND IT WAS CONFIRMED THAT THE INSERT WAS NOT FULLY INSERTED. THE SURGEON REQUESTED AN EVALUATION OF THE INSERT FOR DEFECTS. IN A PHONE CALL WITH A REPRESENTATIVE, IT WAS NOTED THAT THERE WAS NO SURGICAL DELAY, THE PATIENT WAS KEPT OVERNIGHT.

  Patient problems: Insufficient Information

  MAUDE report 19561544 ↗
• InjuryDec 15, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED: "DISLOCATION FROM STEM LOOSENING, AND ASSOCIATED PERIPROSTHETIC FRACTURE (WHEN ATTEMPTING TO REPAIR IT)." THIS RECORD CAPTURES THE DISLOCATION DUE TO THE STEM LOOSENING.

  Patient problems: Joint Dislocation

  MAUDE report 18340881 ↗
• InjuryAug 17, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THERE WAS A REVISION SURGERY CONDUCTED UTILIZING THE BLUEPRINT PLANNING FEATURE. THE PRIMARY IMPLANTS USED IN THIS CASE WERE TORNIER. THE EXPLANTED DEVICES INCLUDED A TORNIER 36 STANDARD GLENOSPHERE AND A REVERSED INSERT. THE REVISION SURGERY WAS NECESSITATED BY DISLOCATION, WITH NO ACCOMPANYING X-RAYS PROVIDED AND NO NOTABLE CIRCUMSTANCES SURROUNDING THE EVENT.

  Patient problems: Joint Dislocation

  MAUDE report 17568956 ↗