Tornier Perform® Anatomic Augmented Glenoid DWK503LA15Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00846832090556), received between Apr 14, 2023 and Apr 3, 2025 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 3, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES PERFORMED UNTIL (B)(6) 2025. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024, A PATIENT REQUIRED REVISION SURGERY DUE TO DISLOCATION/SUBLUXATION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Subluxation

  MAUDE report 21766644 ↗
• InjuryMay 30, 2023Osseointegration Problem; Osseointegration Problem

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES WITH THE TORNIER SHOULDER SYSTEM.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 (B)(6) 2012 ¿ (B)(6) 2022. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2022 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 17020881 ↗
• InjuryApr 14, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THERE WAS A PATIENT UNDERWENT A TOTAL SHOULDER REPLACEMENT. DUE TO INCREASING INSTABILITY IN JOINT OVER RECENT MONTHS, SURGEON DECIDED TO CONVERT THE TSA TO A REVERSE SHOULDER REPLACEMENT. ALL COMPONENTS WERE WELL FIXED. THE GLENOID POLY IMPLANT HAD TO BE BROKEN UP IN-SITU AND REMOVED IN PIECES. THE HUMERAL COMPONENT WAS EXTREMELY WELL FIXED. SIGNIFICANT BONE WAS ATTACHED TO THE CENTRAL CORE/FINS OF THE COMPONENT. A REVERSE ARTHROPLASTY PROSTHESIS WAS IMPLANTED. STABILE RANGE OF MOTION WAS DEMONSTRATED AT THE CONCLUSION OF SURGERY.

  Patient problems: Joint Laxity

  MAUDE report 16744415 ↗