Tornier Perform® Reversed Augmented Glenoid DWJ514Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00846832092130), received between Mar 5, 2024 and Sep 16, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Unstable” (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.

• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  As reported: "Patient has re-presented to surgeon, following revision shoulder arthroplasty in(b)(6)2026. Significant swelling and redness over wound, pain on movement. Wound re-opened, and surgeon concluded that the prosthetic joint was now infected. Decided to remove all prosthesis, as stage 1 of a 2-stage revision. Glenoid component was found to be very loose, easily removed as 1 x construct (revised at previous revision). Humeral component (not revised at previous revision) was found to be extremely well fixed. Humeral poly insert removed - significant wear noted (only been insitu since (b)(6)2026 revision). Proximal humeral vertical osteotomy was required to loosen and to break the bone / implant ongrowth. Stem eventually removed; osteotomy cabled back together with Nice Loops. Multiple tissue specimens collected; debridement; copious lavage attended; no antibiotic spacer implanted - gleno-humeral joint left dis-articulated.Plan - antibiotic regime until clinical markers indicate no infection, then the 2nd stage revision will be undertaken, using a "Custom Glenoid", to be manufactured by a competitor company."

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 50791167 ↗
• InjuryDec 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT.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) 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2018 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 23905582 ↗
• InjuryMar 5, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO INSTABILITY OF THE JOINT. THE DEVICE WAS REMOVED AND REPLACED NEW HARDWARE.

  Patient problems: Joint Laxity; Unspecified Infection

  MAUDE report 18842451 ↗