Tornier Perform® Anatomic Glenoid DWE312Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03700434022278), received between May 12, 2023 and Feb 6, 2026 — classified as 6 injuries.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE PATIENT HAD PAIN. IT WAS ALSO REPORTED. (B)(6) TEAM WERE USED FOR THEIR STEM ONCE THE AEQUALIS AND PERFORM PEGGED WAS REMOVED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 24278378 ↗
• InjuryAug 9, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  SURGEON REVISED AN ANATOMIC SHOULDER REPLACEMENT DUE TO SUB SCAP FAILURE AND REMOVED ALL STRYKER IMPLANTS.

  Patient problems: Joint Dislocation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19950967 ↗
• InjuryJun 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "ADVERSE EVENT: : PATIENT EXPERIENCING PAIN. DIAGNOSED WITH ROTATOR CUFF FAILURE POST ARTHROPLASTY. REQUIRED INTERVENTION TO PREVENT LIFE-THREATENING ILLNESS OR INJURY, OR PERMANENT IMPAIRMENT OR DAMAGE.: YES. ORIGINAL SURGERY ¿ (ANATOMIC CONFIGURATION) DATE OF IMPLANT: (B)(6) 2014. STEM ¿ AEQUALIS ASCEND FLEX 4A STANDARD PTC HUMERAL STEM. HUMERAL HEAD- ASCEND FLEX STANDARD LOW OFFSET 46 X17 AEQUALIS (HUMERAL INDEX 6.5). GLENOID ¿ PERFORM- PEGGED M35. REVISION IMPLANTS ¿ (REVISION TO REVERSED CONFIGURATION) DATE OF REVISION SURGERY: (B)(6) 2024; STEM- RETAINED; EXPLANTATION OF THE FOLLOWING DEVICE COMPONENTS: HUMERAL HEAD- ASCEND FLEX STANDARD LOW OFFSET 46 X17 AEQUALIS (HUMERAL INDEX 6.5); GLENOID ¿ PERFORM- PEGGED M35. IMPLANTATION OF THE FOLLOWING DEVICE COMPONENTS: TRAY- HIGH OFFSET TRAY +0MM; INSERT- STANDARD 36 DIA. (+) 6MM/7.5C; GLENOID- BASEPLATE- PERFORM REVERSED GLENOID- LATERALIZED BASEPLATE (+3MM), 25MM; GLENOID- GLENOSPHERE- STANDARD 36MM DIAMETER".

  Patient problems: Implant Pain; Muscle/Tendon Damage

  MAUDE report 19608332 ↗
• InjuryAug 22, 2023Naturally Worn; Naturally Worn

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES WITH THE TORNIER SHOULDER SYSTEM. THE REPORT DETAILS ANALYSIS PROVIDED FOR PROCEDURES PERFORMED BETWEEN APRIL 2012 ¿ MAY 2022. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2022 A PATIENT REQUIRED REVISION SURGERY DUE TO PERIPROSTHETIC FRACTURE AND GLENOID IMPLANT WEAR. THIS EVEN WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Limb Fracture

  MAUDE report 17599874 ↗
• InjuryMay 26, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SUBLUXATION, INSTABILITY AND PAIN. THE PATIENT UNDERWENT A REVISION PROCEDURE.

  Patient problems: Implant Pain; Subluxation

  MAUDE report 17015117 ↗
• InjuryMay 12, 2023Osseointegration Problem; Migration; Osseointegration Problem; Migration

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES WITH THE TORNIER SHOULDER SYSTEM. THE REPORT DETAILS ANALYSIS PROVIDED FOR PROCEDURES PERFORMED BETWEEN APRIL 2012 ¿ MAY 2022. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2021 A PATIENT REQUIRED REVISION SURGERY DUE " ASEPTIC LOOSENING GLENOID", WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. REVISION PROCEDURE TYPE: "SINGLE STAGE REVISION.¿

  Patient problems: Osteolysis

  MAUDE report 16924907 ↗