Tornier Perform® Reversed Glenoid DWJ002Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00846832091317), received between Mar 27, 2023 and Sep 16, 2026 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Unstable” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 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 50791168 ↗
• InjurySep 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT; A PATIENT WAS BOOKING IN FOR A REVISION PROCEDURE DUE TO ONGOING PAIN AND STIFFNESS. DURING THE DISSECTION LOTS OF FLUID/ PUSS WAS SEEN AND THE DECISION WAS MADE TO DO A 2 STAGE PROCEDURE TO CLEAR THE INFECTION. ANOTHER REVISION PROCEDURE WILL BE NEEDED AFTER THE INFECTION HAS CLEARED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Loss of Range of Motion; Pain; Unspecified Infection

  MAUDE report 23084119 ↗
• InjuryDec 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON USED THE BASEPLATE INSERTER TO ATTEMPT TO REMOVE A BASEPLATE. THE BASEPLATE WAS WELL FIXED AND IT DEFORMED THE BASEPLATE INSERTER. REMOVAL WAS DUE TO PATIENT INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 20860535 ↗
• MalfunctionOct 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT: "LOCKING RING INSIDE 29MM 15 DEGREE FULL WEDGE BASEPLATE (DWJ515) SN: (B)(6)". IT WAS REPORTED THAT DURING IMPLANTATION OF PERIPHERAL SCREWS, THE LOCKING RING IN THE BASEPLATE CAME LOOSE AND FELL OUT. THE SURGEON HAD TO USE ANOTHER BASEPLATE AFTER REMOVING DEFECTIVE ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20501319 ↗
• 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 18842447 ↗
• InjuryFeb 20, 2024Osseointegration Problem; Migration; Osseointegration Problem; Migration

  COMPONENT LOOSENING OCCURRED, WITH THE SUBJECT REPORTING PAIN AND CONTACTING THE SURGEON'S OFFICE. RADIOGRAPHS REVEALED A BROKEN INFERIOR SCREW IN THE BASEPLATE AND SHIFTING OF THE BASEPLATE, WHICH WAS CONFIRMED BY A CT SCAN. THE SUBJECT UNDERWENT A REVISION PROCEDURE, AND THE OUTCOME WAS RESOLVED WITHOUT ANY SEQUELAE. PREVIOUS ADVERSE EVENTS FOR THIS PATIENT WERE RECORDED AS ANTERIOR SUBLUXATION OF THE RIGHT SHOULDER WITH FAILURE OF THE SUBSCAPULARIS REPAIR AND MINIMALLY DISPLACED POSTERIOR INFERIOR GLENOID FRACTURE.

  Patient problems: Implant Pain; Inadequate Osseointegration

  MAUDE report 18740864 ↗
• InjuryJun 26, 2023Device 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 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 4 MARCH 2020 A PATIENT REQUIRED REVISION SURGERY DUE TO COMPONENT DISSOCIATION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. REVISION PROCEDURE TYPE : SINGLE STAGE REVISION.

  Patient problems: Joint Dislocation

  MAUDE report 17199697 ↗
• InjuryMar 27, 2023Unstable; Unstable

  PATIENT UNDERWENT REVISION SURGERY. THE PATIENT NOTICED SHOULDER INSTABILITY. A SMALL CYSTS WAS NOTICED ON THE SHOULDER AND AN ULTRASOUND/ BIOPSY WAS COMPLETED. THE POST OP INFECTION WAS CONFIRMED. DURING THE REVISION, ALL DEVICES WERE EXPLANTED AND REPLACED WITH A SPACER.

  Patient problems: Bacterial Infection; Cyst(s); Joint Laxity

  MAUDE report 16619174 ↗