Tornier Perform® Reversed Glenoid DWJ001Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00846832091614), received between Oct 27, 2023 and Sep 18, 2026 — classified as 12 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jan 3, 2024Class IIOpen, Classified

   The incorrect device is contained in the labeled package.

   Z-0773-2024 · Root cause: Packaging process control · Recall details · FDA record ↗

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 18, 2026Device Dislodged or Dislocated

  The manufacturer received a report from the National Joint Registry that contains unpublished collected data on the usage and the outcomes of the shoulder joint replacement. The report details analysis provided for revision procedures performed until Aug 2026.During the review of the report, it was identified that on (b)(6) 2025 a patient required revision surgery due to INFECTION, DISLOCATION/SUBLUXATION, which was not previously reported to the manufacturer.

  Patient problems: Subluxation; Unspecified Infection

  MAUDE report 50820937 ↗
• InjurySep 11, 2026Unstable

  Patient problems: Insufficient Information

  MAUDE report 50735225 ↗
• InjuryAug 24, 2026Adverse Event Without Identified Device or Use Problem

  All implants were removed due to suspected infection.

  Patient problems: Post Operative Wound Infection

  MAUDE report 50412877 ↗
• InjuryMay 29, 2026Loss of Osseointegration; Naturally Worn

  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 25331629 ↗
• InjuryMar 23, 2026Osseointegration Problem

  IT WAS REPORTED THAT, THE PATIENT HAD ORIF PROXIMAL HUMERUS CONVERTED TO AN AUGMENTED RSA, THE ASEPTIC LOOSENING CONTRIBUTED BY SUBOPTIMAL SEATING OF THE BASEPLATE, BONE QUALITY WAS GOOD. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 24669332 ↗
• 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 24066676 ↗
• 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 23438372 ↗
• InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT: (B)(6). REVIVE HRS STUDY. PATIENT SEEN FOR SWELLING AND PAIN OF RIGHT SHOULDER (OPERATED SHOULDER). ACCORDING TO THE SURGEON, THIS EVENT IS NOT RELATED TO THE DEVICE OR THE SURGERY.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 22663557 ↗
• InjurySep 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "REVISION OF REVERSE SHOULDER WHICH WAS IMPLANTED ON (B)(6) 2024, PATIENT HAD NERVE PROBLEMS, SURGEON SUSPECTED THE GLENOID WAS TOO LATERALIZED WITH THE WEDGE IMPLANT SO WANTED TO REVISE TO A STANDARD BASE PLATE- ALL IMPLANTS FROM THE PREVIOUS CASE EXCEPT THE ASCEND HUMERAL STEM WERE REPLACED WITH NEW IMPLANTS".

  Patient problems: Nerve Damage

  MAUDE report 20208951 ↗
• 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 19205358 ↗
• 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 18681614 ↗
• InjuryOct 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY WAS PERFORMED DUE TO A SUSPECTED INFECTION. THE HARDWARE WAS REMOVED, AND A CEMENT SPACER WAS IMPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 18022143 ↗