Tornier Perform® Reversed Glenoid DWJ730Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00846832091256), received between May 15, 2023 and Sep 16, 2026 — classified as 12 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (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 12 most recent of 12 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) '26 revision). Proximal humeral vertical osteotomy was required to loosen and to break the bone / implant on growth. 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 50791181 ↗
• InjuryJul 7, 2026Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT PRIMARY REVERSE SHOULDER ARTHROPLASTY. AT APPROXIMATELY TWO-YEAR FOLLOW-UP, THE PATIENT PRESENTED WITH SHOULDER PAIN AND REDUCED RANGE OF MOTION. THE SURGEON NOTED REPORTED NON-COMPLIANCE WITH POSTOPERATIVE REHABILITATION AND A HISTORY OF POTENTIAL TRAUMA WHILE CLIMBING IN AND OUT OF A TRUCK. DURING REVISION SURGERY, THE GLENOID COMPONENT WAS FOUND TO BE LOOSE AND DISSOCIATED FROM THE GLENOID BONE AND WAS EASILY REMOVED. THE HUMERAL COMPONENT REMAINED WELL FIXED AND WAS RETAINED. THE POLYETHYLENE INSERT EXHIBITED ECCENTRIC WEAR, AND GREY SYNOVIAL TISSUE WAS OBSERVED AND EXCISED. COPIOUS LAVAGE WAS PERFORMED. NEW GLENOID COMPONENTS WERE IMPLANTED WITH THE ADDITION OF SYNTHETIC BONE GRAFT. A NEW HUMERAL POLYETHYLENE INSERT WAS PLACED. THE SHOULDER WAS REDUCED AND FOUND TO BE STABLE THROUGH RANGE OF MOTION.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 25735486 ↗
• InjuryJun 24, 2026Adverse Event Without Identified Device or Use Problem

  REVISION OF ASCEND FLEX REVERSE STEM WITH PERFORM REVERSED GLENOID DUE TO INFECTION.

  Patient problems: Post Operative Wound Infection

  MAUDE report 25604395 ↗
• InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "BECAUSE THE PATIENT WAS EXPERIENCING PAIN, A REVISION SURGERY WAS PERFORMED TO DETERMINE IF THE IMPLANT WAS LOOSE OR NEEDED RESIZING. A SLIGHT FOREIGN BODY REACTION SUGGESTIVE OF INFECTION WAS OBSERVED."

  Patient problems: Pain; Unspecified Infection

  MAUDE report 25340594 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE PATIENT UNDERWENT LEFT REVERSE SHOULDER REPLACEMENT ON (B)(6) 2025. PT EXPERIENCED A VERY POSITIVE POST-OP REHAB / RECOVERY, DEMONSTRATING (ACCORDING TO THE SURGEON) A FULL RANGE OF MOTION OF HIS PROSTHETIC SHOULDER JOINT, WITHIN 6 WEEKS POST-OP. LATER, PATIENT WAS RIDING A PUSH BIKE (IN THE EARLY HOURS OF THE MORNING), AND FELL OFF, DISLOCATING HIS LEFT SHOULDER JOINT. UNABLE TO BE CLOSED REDUCED. SURGEON DECIDED ON A MUA, BOOKED FOR (B)(6) 2025. JOINT REDUCED, UNDER ANESTHESIA, BUT GROSSLY UNSTABLE. SURGEON DECIDED ON AN OPEN PROCEDURE. TORNIER FLEX REVERSED 0MM TRAY WAS REMOVED, ALONG WITH THE TORNIER REVERSED INSERT 39MM/9MM, AND A THICKER TRAY (6MM) AND (SAME SIZE) NEW INSERT WERE IMPLANTED. ON REDUCTION, THE JOINT WAS STILL UNSTABLE. SURGEON DISLOCATED THE JOINT, REMOVED THE NEW REVERSE TRAY / POLY INSERT, AND PROCEEDED TO EXPLORE FOR FURTHER CAUSES OF THE IMPINGEMENT / INSTABILITY. MORE POSTERO-INFERIOR GLENOID BONE WAS REMOVED. THE (PRIMARY) IMPLANTED 39MM STANDARD GLENOSPHERE WAS THEN REMOVED, REPLACED BY A 42MM STANDARD GLENOSPHERE. THE SUPERIOR GLENOID 30MM SCREW WAS FOUND TO BE LOOSE, AND REPLACED WITH A 34MM SCREW. A NEW 12MM FLEX REVERSE TRAY

  Patient problems: Fall; Subluxation

  MAUDE report 24067088 ↗
• InjuryJun 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REVERSE SHOULDER ARTHROPLASTY WAS DONE FOR INFECTION. THE SURGEON MENTIONED ENTEROCOCCI WAS DETECTED. THE IMPLANTS WERE REMOVED AND CEMENT SPACER WAS IMPLANTED. NO PRODUCT FAULT WAS REPORTED.

  Patient problems: Bacterial Infection

  MAUDE report 22158546 ↗
• InjuryJun 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REVERSE SHOULDER ARTHROPLASTY WAS DONE FOR INFECTION. THE SURGEON MENTIONED ENTEROCOCCI WAS DETECTED. THE IMPLANTS WERE REMOVED AND CEMENT SPACER WAS IMPLANTED. NO PRODUCT FAULT WAS REPORTED.

  Patient problems: Bacterial Infection

  MAUDE report 22158544 ↗
• InjuryMar 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN INFECTION WAS FOUND IN THE KNEE AND SPINE IMPLANT, AND THE SHOULDER WAS ALSO SUSPECTED OF BEING INFECTED. THE REVISION SURGERY FOR REMOVING IMPLANTS WAS SCHEDULED ON (B)(6) 2025.

  Patient problems: Medical device site infection

  MAUDE report 21699146 ↗
• InjuryJul 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD PAIN AND A SCREW WAS TO BE REMOVED AS IT WAS TOUCHING A NERVE. WITH THE SCREW NEEDING TO BE REMOVED THE SURGEON WISHED TO IMPLANT A NEW GLENOSPHERE, TRAY AND POLY AT THE SAME TIME. THERE WAS NO MALFUNCTION OR ISSUE WITH THE IMPLANTS/PRODUCTS USED IN THE PRIMARY SURGERY. IT WAS JUST THAT ONE SCREW WAS TOO LONG AND NEEDED TO BE REMOVED AND SO THE OTHER IMPLANTS WERE EXCHANGED.

  Patient problems: Implant Pain

  MAUDE report 19839001 ↗
• InjuryApr 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION"

  Patient problems: Unspecified Infection

  MAUDE report 19205347 ↗
• 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 16989720 ↗
• InjuryMay 15, 2023Off-Label Use; Osseointegration Problem; Off-Label Use; Osseointegration Problem

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

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 16935400 ↗