Tornier Perform® Reversed Glenoid DWJ734Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00846832091263), received between Jan 19, 2023 and Sep 16, 2026 — classified as 10 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 11 most recent of 11 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 50791173 ↗
• InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT: (B)(6). (B)(4) STUDY. REPLACEMENT OF THE COMPLETE PROSTHESIS DUE TO CHRONIC LOW-GRADE INFECTION. (LEUKOCYTES 8. G/L, CRP 17.7 MG/L, CELL COUNT: 12,300, 98% POLYNUCLEAR: MIBI FROM PUNCTURE: RENEWED DETECTION OF CUTIBACTERIUM ACNES IN THE CULTURE, PENICILLIN-SENSITIVE)

  Patient problems: Unspecified Infection

  MAUDE report 24232030 ↗
• InjuryMay 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PHS STUDY SUBJECT: (B)(6). DEEP INFECTION REQUIRING A MEDICAL INTERVENTION (OPENED DEBRIDEMENT AND IRRIGATION). INFECTION C. ACNES. RE-OPERATION WITHOUT IMPLANT EXTRACTION. DATE OF REOPERATION: (B)(6) 2025".

  Patient problems: Unspecified Infection

  MAUDE report 21948042 ↗
• InjuryApr 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION FOR SUSPECTED INFECTION. REMOVAL OF ALL IMPLANTS (REVERSE SHOULDER REPLACEMENT) AND IMPLANTATION OF CEMENT SPACER.

  Patient problems: Medical device site infection

  MAUDE report 21797687 ↗
• InjuryApr 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION FOR SUSPECTED INFECTION. REMOVAL OF ALL IMPLANTS (REVERSE SHOULDER REPLACEMENT) AND IMPLANTATION OF CEMENT SPACER.

  Patient problems: Medical device site infection

  MAUDE report 21797411 ↗
• MalfunctionJun 25, 2024Break; Fracture; Break; Fracture

  AS REPORTED: "ON (B)(6) 2024, IN THE ORTHOPAEDIC SURGERY UNIT, DURING A REVISION OF A SHOULDER PROSTHESIS, A SCREW BELONGING TO THE NEW SHOULDER PROSTHESIS BROKE INSIDE THE PROSTHESIS. IT WAS NOT POSSIBLE TO RECOVER THE ENTIRE SCREW AND A PIECE REMAINED IN THE PATIENT. THERE WERE NO CONSEQUENCES FOR THE PATIENT AND THIS WAS AN ISOLATED EVENT. THE DEVICE INVOLVED IN THIS INCIDENT IS SOILED AND AVAILABLE FROM THE PHARMACY."

  Patient problems: Foreign Body In Patient

  MAUDE report 19607302 ↗
• 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 WITH NEW HARDWARE.

  Patient problems: Joint Laxity; Unspecified Infection

  MAUDE report 18842507 ↗
• 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 AN INFECTION. THE DEVICE WAS REMOVED AND REPLACED WITH A CEMENT SPACER.

  Patient problems: Joint Laxity; Unspecified Infection

  MAUDE report 18842505 ↗
• InjuryMay 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE WAS A REVISION SURGERY CAUSED BY AN INFECTION. ADDITIONALLY, ALL TEN IMPLANTS WERE REMOVED. THE NURSE STILL HAD THE CENTRAL SCREW WITHIN THE BASEPLATE AND THE REVERSED INSERT WAS UNATTACHED FROM THE REVERSED TRAY.

  Patient problems: Unspecified Infection

  MAUDE report 16989770 ↗
• InjuryMay 12, 2023Off-Label Use; Osseointegration Problem; Off-Label Use; Osseointegration Problem

  THERE WAS AN EARLY REVISION OF A PERFORM REVERSED GLENOID IMPLANTED. FLUIDS AND TISSUES HAVE BEEN HARVESTED DURING THE REVISION CASE FOR A SUSPECTED INFECTION. THERE IS NO RESULTS OF THE PATHOLOGY TESTS. ONCE THE REVERSE GLENOID WAS REMOVED, THE SURGEON PACKED THE GLENOID VAULT WITH SOME FEMORAL HEAD GRAFT AND HAS CONVERTED THE STEM TO A HEMI PROSTHESIS. THE STEM WAS NOT REVISED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16924374 ↗
• InjuryJan 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFECTION WAS FOUND IN A PATIENT AFTER ARTIFICIAL SHOULDER JOINT SURGERY.

  Patient problems: Unspecified Infection

  MAUDE report 16203352 ↗