Tornier Perform® Reversed Glenoid DWJ326Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00846832088447), received between Jan 24, 2023 and Sep 11, 2026 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2026Loosening of Implant Not Related to Bone-Ingrowth

  Patient problems: Inadequate Osseointegration

  MAUDE report 50742273 ↗
• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A REVISION SURGERY. PATIENT HAD SHOWN SIGNS OF INFECTION AND WAS DRAINING FROM THE HEALED INCISION SITE. NO INSTABILITY WAS REPORTED OR OBSERVED. CULTURES WERE PERFORMED INTRAOPERATIVELY. THE PATIENTS 3YR OLD WOUND WAS DRAINING FOR THE LAST 3-4 WEEKS AND THE DOCTOR DECIDED TO REMOVE ALL THE IMPLANTS AND IMPLANT AN ANTIBIOTIC SPACER.

  Patient problems: Fluid Discharge; Post Operative Wound Infection

  MAUDE report 24482393 ↗
• InjuryOct 31, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT DURING REVISION SURGERY FOR A LOOSE BASEPLATE OF A PRIOR TORNIER RSA CONSTRUCT, THE SURGEON ATTEMPTED IMPLANTATION OF A ZIMMER BIOMET VRS DEVICE. THE VRS IMPLANT DISASSOCIATED FROM THE BONE INTRAOPERATIVELY, AND THE PROCEDURE WAS COMPLETED WITH IMPLANTATION OF A REVIVE HEMIARTHROPLASTY COMPONENT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23438834 ↗
• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT REVISION SURGERY DUE TO ALLEGED PAIN AND SUPERIOR MIGRATION OF THE GLENOID IMPLANTS.

  Patient problems: Pain

  MAUDE report 22375677 ↗
• InjuryMay 16, 2024Break; Fracture; Migration; Break; Fracture; Migration

  THE PRIMARY REVERSE PROCEDURE EMPLOYED TORNIER IMPLANTS, INCLUDING THE SHOULDER ID BASEPLATE AND PERFORM HUMERAL. THE OBSERVED BASEPLATE FAILURE IS ATTRIBUTED TO LIKELY OVER-LATERALIZATION, STEMMING FROM THE THICKNESS OF THE SHOULDER ID BASEPLATE AND A LATERALIZED GLENOSPHERE. THERE WAS ALSO A NOTED SCREW BREAKAGE.

  Patient problems: Failure of Implant

  MAUDE report 19328840 ↗
• InjuryMay 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER UNDERGOING REVISION SURGERY, THE PATIENT BECAME INFECTED, LEADING TO THE REMOVAL OF ALL IMPLANTS. THE INFECTION WAS DISCOVERED BY THE SURGEON, LOCALIZED IN THE SHOULDER JOINT. THE SURGERY TO REMOVE THE IMPLANTS OCCURRED SHORTLY AFTERWARD. MICROORGANISMS WERE NOT IDENTIFIED, AND THERE WAS NO PRIOR INFECTION NEAR THE SURGICAL SITE. THE STERILE BARRIER OF THE DEVICE PACKAGE REMAINED INTACT, AND NO RE-STERILIZATION WAS PERFORMED BEFORE SURGERY. NO ENVIRONMENTAL MONITORING ALERTS WERE RECORDED BEFORE THE SURGERY. THE INFECTION WAS REPORTED BY THE SURGEON, WHO THEN PROCEEDED TO REMOVE ALL IMPLANTS AND INSERT A CEMENT SPACER.

  Patient problems: Unspecified Infection

  MAUDE report 19235330 ↗
• InjuryMay 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER UNDERGOING REVISION SURGERY, THE PATIENT BECAME INFECTED, LEADING TO THE REMOVAL OF ALL IMPLANTS. THE INFECTION WAS DISCOVERED BY THE SURGEON, LOCALIZED IN THE SHOULDER JOINT. THE SURGERY TO REMOVE THE IMPLANTS OCCURRED SHORTLY AFTERWARD. MICROORGANISMS WERE NOT IDENTIFIED, AND THERE WAS NO PRIOR INFECTION NEAR THE SURGICAL SITE. THE STERILE BARRIER OF THE DEVICE PACKAGE REMAINED INTACT, AND NO RE-STERILIZATION WAS PERFORMED BEFORE SURGERY. NO ENVIRONMENTAL MONITORING ALERTS WERE RECORDED BEFORE THE SURGERY. THE INFECTION WAS REPORTED BY THE SURGEON, WHO THEN PROCEEDED TO REMOVE ALL IMPLANTS AND INSERT A CEMENT SPACER.

  Patient problems: Unspecified Infection

  MAUDE report 19231531 ↗
• InjuryMar 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 18972498 ↗
• InjuryMar 12, 2024Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT INITIALLY HAD A ZB HEMI SHOULDER REPLACEMENT. THE LONG ZB STEM WAS REMOVED, AND A REVIVE WITH PERFORM REVERSE IMPLANT WAS IMPLANTED. THE PATIENT LATER REQUIRED A SECOND REVISION TO A REVIVE HEMI FROM TORNIER REVIVE WITH PERFORM REVERSE DUE TO SIGNIFICANT PROXIMAL BONE RECESSION. THE STEM WAS WELL FIXED, SO EVERYTHING ON THE GLENOID SIDE WAS REMOVED, AND A 52 X 23 FLEX HEAD WAS INSTALLED.

  Patient problems: Inadequate Osseointegration; Osteolysis

  MAUDE report 18890070 ↗
• MalfunctionJan 24, 2023Break; Fracture; Mechanical Jam; Break; Fracture; Mechanical Jam

  IT WAS REPORTED THAT 3 PERIPHERAL SCREWS BROKE OFF AT THE NECK OF THE SCREW WHILE IMPLANTING. ALL 3 INCIDENT HAVE BEEN THE EXACT SAME SCENARIO IN ALL 3 CASES THE SURGEON DRILLED THE PERIPHERAL SCREW HOLE AND THEN MEASURED FOR SCREW DEPTH AND STARTED TO IMPLANT CORRESPONDING SCREW. ONCE THE SCREW WAS ABOUT 90% IMPLANTED IT WOULD STOPPED TURNING. THE SURGEON IN EACH SCENARIO THEN ATTEMPTED TO BACK OUT THE SCREW AND IT WOULD NOT BACK OUT OR ADVANCE ANY MORE. THE SURGEON THEN CONTINUED TRYING TO BACK OUT THE SCREW UNTIL IT FINALLY SNAPPED 3-4 THREADS DOWN THE SCREW. THE SURGEON WENT ABOUT A NORMAL TECHNIQUE TO COMPLETE THE SURGERY. ALL THE DEBRIS WAS SUCCESSFULLY REMOVED FROM THE FIELD/PATIENT. PRODUCTS WILL NOT BE RETURNING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16234152 ↗