Tornier Perform® Anatomic Glenoid DWE402Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03700434021165), received between Apr 20, 2023 and Aug 28, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Migration” (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 16, 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.

• InjuryAug 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A REVISION SURGERY DUE TO AN INFECTION CAUSED BY P. ACNES, AS IDENTIFIED BY THE BACTERIAL CULTURE. NO OTHER CONTRIBUTING FACTORS WERE REPORTED, AND THE IMPLANTS WERE DISCARDED AFTER THE PROCEDURE.

  Patient problems: Bacterial Infection

  MAUDE report 20091431 ↗
• InjuryAug 27, 2024Migration; Migration

  IT WAS REPORTED THAT IN 2019, THE PATIENT RECEIVED A RIGHT SHOULDER REPLACEMENT WITH A TORNIER AEQUALIS ASCEND IMPLANT AND EXPERIENCED PAIN AND NUMBNESS IN HER SHOULDER, ARM, AND HAND AFTERWARD. ALTHOUGH X-RAYS TAKEN SHOWED NO ISSUES, HER PAIN WORSENED, LIMITING ARM MOVEMENT. IN 2024, SHE UNDERWENT A REVERSE SHOULDER REPLACEMENT AFTER DISCOVERING THAT A PART OF THE IMPLANT HAD COME LOOSE, DAMAGING THE ROTATOR CUFF AND CAUSING SHOULDER SEPARATION. THE SURGEON FOUND THAT THE LOOSE PIECE WAS "CHEWED UP," CREATING SEVERE SCAR TISSUE, WITH THE POLYETHYLENE GLENOID REPORTED AS GROSSLY LOOSE, CAUSING A CENTRAL CAVITARY DEFECT. THE STEM WAS RETAINED, WHILE OTHER COMPONENTS WERE DISCARDED. THE PATIENT HAD A LEFT SHOULDER REPLACEMENT IN 2015 WITH NO COMPLICATIONS.

  Patient problems: Muscle/Tendon Damage; Numbness; Pain

  MAUDE report 20081306 ↗
• InjuryOct 23, 2023Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  AS REPORTED: "REVISION CASE OF A TOTAL ANATOMIC TO A REVERSE SHOULDER. IMPLANTS REMOVED HUMERAL HEAD AND GLENOID PEGGED IMPLANT. THE PATIENT HAD A BIG FALL AND THEN AFTER THAT, THE GLENOID IMPLANT LOOSENED AND PATIENT NEEDED REVISION SURGERY DUE TO HER MUSCLES FAILING." THE GLENOID IMPLANT HAD COMPLETELY LOOSENED AND WAS NO LONGER IN THE CORRECT SPOT. IT WAS FLOATING LOOSE ON THE PATIENTS JOINT AND SHE HAD PAIN AND HENCE NEEDED THE REVISION SURGERY. "

  Patient problems: Fall; Implant Pain

  MAUDE report 17990684 ↗
• InjuryApr 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A REVISION SURGERY DUE TO A ROTATOR CUFF INSUFFICIENCY.

  Patient problems: Inadequate Osseointegration; Muscle/Tendon Damage

  MAUDE report 16781865 ↗