Tornier Perform® Reversed Augmented Glenoid DWJ505Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 00846832092109), received between Jan 17, 2023 and Sep 17, 2026 — classified as 46 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Osseointegration Problem” (7 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 25 most recent of 49 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  The manufacturer received a report from the National Joint Registry that contains unpublished collected data on the usage and the outcomes of the shoulder joint replacement.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 (b)(6) 2026.During the review of the report, it was identified that on (b)(6) 2026 a patient required revision surgery due to infection & lysis- glenoid, which was not previously reported to the manufacturer.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 50803905 ↗
• InjuryMay 29, 2026Loss of Osseointegration; Device Dislodged or Dislocated; Osseointegration 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: Inadequate Osseointegration; Loss of Range of Motion; Pain

  MAUDE report 25331633 ↗
• InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem

  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 FOR THE MONTHLY REPORT OF (B)(6) 2026. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2026, A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 25229277 ↗
• InjuryMay 18, 2026Fracture

  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 BETWEEN (B)(6) 2025 - (B)(6) 2026. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2026, A PATIENT REQUIRED REVISION SURGERY DUE TO PERIPROSTHETIC FRACTURE/IMPLANT FRACTURE, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Bone Fracture(s)

  MAUDE report 25198405 ↗
• InjuryFeb 23, 2026Unstable

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES PERFORMED BETWEEN (B)(6) 2023 - (B)(6) 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024 A PATIENT REQUIRED REVISION SURGERY DUE TO INSTABILITY, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Joint Laxity

  MAUDE report 24413932 ↗
• InjuryFeb 12, 2026Failure to Osseointegrate

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES PERFORMED BETWEEN MARCH 2023 - SEPTEMBER 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2023 A PATIENT REQUIRED REVISION SURGERY DUE TO ASEPTIC LOOSENING GLENOID, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Osteolysis

  MAUDE report 24323838 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  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 (B)(6) 2025. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2025 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, PERIPROSTHETIC FRACTURE & LYSIS- GLENOID, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Bone Fracture(s); Osteolysis; Unspecified Infection

  MAUDE report 23957848 ↗
• InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES PERFORMED BETWEEN (B)(6) 2023 - (B)(6) 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 23550356 ↗
• InjuryOct 30, 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 23427141 ↗
• InjuryOct 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING THE SURGERY, A BONE FRACTURE OCCURRED ON THE ARTICULAR SURFACE OF THE GLENOID. THE SURGERY ITSELF WAS COMPLETED WITH THE IMPLANT PLACED AS PLANNED, NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Bone Fracture(s)

  MAUDE report 23252642 ↗
• InjurySep 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SHOULDER ARTHROPLASTY WAS PERFORMED TO CONVERT AN ANTIBIOTIC SPACER TO A REVERSE SHOULDER CONSTRUCT. THE PATIENT PREVIOUSLY UNDERWENT A PRIMARY PROCEDURE WITH TORNIER/STRYKER IMPLANTS, WHICH WERE LATER EXPLANTED DUE TO INFECTION. AN ANTIBIOTIC SPACER WAS PLACED AT THAT TIME. DURING THE MOST RECENT PROCEDURE, THE SPACER WAS REMOVED AND REPLACED WITH A REVERSE SHOULDER PROSTHESIS.

  Patient problems: Post Operative Wound Infection

  MAUDE report 23125593 ↗
• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain

  MAUDE report 22375911 ↗
• InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT: 12-008. PHS STEMLESS IDE STUDY. PARTICIPANT HAS BEEN EXPERIENCING PAIN, WITH NO KNOWN CASE.

  Patient problems: Pain

  MAUDE report 22327656 ↗
• InjuryJun 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 (B)(6) 2025. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 22177086 ↗
• InjuryJun 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SURGEON UTILIZED MAKO SHOULDER IN A CASE WITH IMPLANTATION OF FULL WEDGE AUGMENT BASEPLATES (TORNIER PERFORM REVERSED AUGMENTED GLENOID) WITH A PRESS-FIT POST. HE REPORTED THAT "AFTER INSTALLING PERFORM BASEPLATE AND DRILLING FOR PERIPHERAL SCREWS - NOTICED GLENOID WAS FRACTURED".

  Patient problems: Bone Fracture(s)

  MAUDE report 22160860 ↗
• InjuryMay 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A FRACTURE DURING MAKO SHOULDER CASE WHEN IMPLANTING A BASEPLATE AND THE GLENOID FRACTURED.

  Patient problems: Bone Fracture(s)

  MAUDE report 22086984 ↗
• InjuryMay 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 (B)(6) 2025. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 22083359 ↗
• InjuryMay 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 (B)(6) 2025. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2025 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 22083358 ↗
• MalfunctionMay 23, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE INTERNAL NUT OF BOSS WAS BLOCKING THE ABILITY OF THE CENTRAL SCREW TO BE LOADED INTO THE FULL WEDGE BASEPLATE. A NEW DEVICE WAS OPENED TO COMPLETE THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 22078120 ↗
• InjuryMay 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "SUBJECT: (B)(6), PERFORM FRACTURE STUDY. SUBJECT HEARD A "POP" IN HER SHOULDER WHILE GETTING DRESSED ON (B)(6) 2024. SHE BEGAN EXPERIENCING PAIN WITH MOVEMENT. SHE UNDERWENT SHOULDER X-RAYS WHICH DEMONSTRATED A MINIMALLY DISPLACED CORACOID STRESS FRACTURE."

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 21993355 ↗
• MalfunctionApr 22, 2025Mechanical Jam; Mechanical Jam

  DURING PRIMARY SURGERY IT WAS REPORTED BY THE CUSTOMER THAT THE CENTRAL SCREW GOT STUCK IN THE BASEPLATE WHILE FIXING IT IN GLENOID. THE SCREW OF APPROPRIATE DIAMETER WAS USED AND COULD NOT BE REMOVED. LATER IT WAS REPLACED BY A POST.

  Patient problems: Insufficient Information

  MAUDE report 21880851 ↗
• 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 21796755 ↗
• InjuryApr 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "SUBJECT: (B)(6) PHS STEMLESS IDE STUDY: SCAPULAR FRACTURE: UPDATE ON 10 MAR 2025: NO ACTION TAKEN. SITE REPORTS: SURGERY WAS DISCUSSED BUT DECIDED AGAINST".

  Patient problems: Bone Fracture(s)

  MAUDE report 21765564 ↗
• 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 21698912 ↗
• InjuryMar 26, 2025Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem

  PATIENT UNDERWENT PRIMARY OPERATION IN (B)(6) 2023. HAD INCREASING PAIN IN OPERATED SHOULDER AND SOUGHT MEDICAL ADVICE WITH NON-PRIMARY SURGEON. X-RAYS AND CT SCANS SHOWED BASEPLATE WAS NOT FIXED TO SCAPULAR AND WAS SITTING WITHIN THE JOINT. ALSO SHOWED SIGNIFICANT BONE LOSS TO REMAINING GLENOID. DECISION MADE TO REVISE IMPLANT. ORIGINAL IMPLANTS REMOVED. BONE LOSS TOO SIGNIFICANT TO DO A SINGLE STAGE REVISION. PRIMARY FIXATION OF IMPLANT NOT ACHIEVED BY PRIMARY SURGEON. LOOSE IMPLANT CAUSED SIGNIFICANT BONE LOSS IN GLENOID. REVISION SURGERY REQUIRED (MULTIPLE STAGES).

  Patient problems: Inadequate Osseointegration; Joint Dislocation; Pain

  MAUDE report 21698101 ↗