Tornier Perform® Reversed Glenoid DWJ330Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00846832089406), received between Feb 9, 2024 and Sep 11, 2026 — classified as 16 injuries, 1 malfunction.

The most frequently reported specific device problem is “Osseointegration Problem” (3 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 17 most recent of 17 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 50742267 ↗
• 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 24482690 ↗
• 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 24482419 ↗
• 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 23441364 ↗
• 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 23438835 ↗
• InjuryJun 19, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT IS STATUS POST RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY. ONE OF THE SCREWS FROM THE IMPLANTS CAME LOOSE AND FRACTURED THE SCAPULA, CAUSING PAIN.

  Patient problems: Bone Fracture(s); Inadequate Osseointegration; Pain

  MAUDE report 22294221 ↗
• MalfunctionMar 20, 2025Residue After Decontamination; Residue After Decontamination

  IT WAS REPORTED THAT THERE WAS A WHITE SUBSTANCE ON ALL OF THE PERIPHERAL SCREWS IN A YKAD261 TRAY. IT APPEARED TO BE A FIBROUS MATERIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21653728 ↗
• InjuryJan 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL RESULTING IN A PERIPROSTHETIC FRACTURE. ALL IMPLANTED COMPONENTS WERE REMOVED, AND A REVERSE PROSTHESIS WAS PLACED. NO IMAGES WERE PROVIDED. THE EXPLANTED IMPLANTS WERE NOT AVAILABLE FOR EVALUATION PER HOSPITAL POLICY REQUIRING DISPOSAL OF EXPLANTED ITEMS.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 21242205 ↗
• InjurySep 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A ONE STAGE REVISION DUE TO AN ACUTE INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 20326832 ↗
• InjurySep 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A ONE STAGE REVISION DUE TO AN ACUTE INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 20325262 ↗
• InjuryJul 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE EXPLANT WAS DUE TO AN INFECTION. THE INFECTION WAS DETECTED DURING A POST-OP FOLLOW-UP AND LOCALIZED IN THE ANTERIOR INFERIOR DELTOPECTORAL INCISION. THE MICROORGANISM IDENTIFIED WAS C. ACNES. THE PATIENT HAD NO PRIOR INFECTIONS NEAR THE SURGERY SITE. THE STERILE BARRIER OF THE DEVICE PACKAGE WAS NOT COMPROMISED, AND NO RE-STERILIZATION OF THE DEVICE WAS PERFORMED BEFORE SURGERY. NO ENVIRONMENTAL MONITORING ALERTS RELATED TO THE DEVICE¿S STORAGE WERE RECORDED. THE INFECTION WAS RESOLVED BY PROSTHESIS EXPLANTATION AND INSERTION OF AN ANTIBIOTIC CEMENT SPACER. THE SURGEON NOTICED MILD INFLAMMATION AND REFERRED THE PATIENT TO INFECTIOUS DISEASE FOR ANTIBIOTICS.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 19774101 ↗
• InjuryJul 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE EXPLANT WAS DUE TO AN INFECTION. THE INFECTION WAS DETECTED DURING A POST-OP FOLLOW-UP AND LOCALIZED IN THE ANTERIOR INFERIOR DELTOPECTORAL INCISION. THE MICROORGANISM IDENTIFIED WAS C. ACNES. THE PATIENT HAD NO PRIOR INFECTIONS NEAR THE SURGERY SITE. THE STERILE BARRIER OF THE DEVICE PACKAGE WAS NOT COMPROMISED, AND NO RE-STERILIZATION OF THE DEVICE WAS PERFORMED BEFORE SURGERY. NO ENVIRONMENTAL MONITORING ALERTS RELATED TO THE DEVICE¿S STORAGE WERE RECORDED. THE INFECTION WAS RESOLVED BY PROSTHESIS EXPLANTATION AND INSERTION OF AN ANTIBIOTIC CEMENT SPACER. THE SURGEON NOTICED MILD INFLAMMATION AND REFERRED THE PATIENT TO INFECTIOUS DISEASE FOR ANTIBIOTICS.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 19766412 ↗
• 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 19235113 ↗
• 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 19235107 ↗
• 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 18972582 ↗
• 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 18891000 ↗
• InjuryFeb 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS HAVING BILATERAL INCISION PAIN. THERE ARE NO HARDWARE COMPLICATIONS. X-RAYS AT 12 MONTHS CONFIRMED NO HARDWARE COMPLICATION. PLAN TO WORK UP FOR INFLAMMATORY ISSUES, REFERRAL TO RHEUMATOLOGY, PAIN CLINIC AND MRI OF CERVICAL SPINE TO RULE OUT RADICULOPATHY.

  Patient problems: Pain

  MAUDE report 18681611 ↗