Tornier Perform® Reversed Augmented Glenoid DWJ515Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00846832092147), received between Jul 18, 2022 and Aug 7, 2026 — classified as 23 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2026Device Dislodged or Dislocated

  It was reported that the patient underwent a revision procedure due to a suspected infection and dislocation of the implant.

  Patient problems: Joint Dislocation; Post Operative Wound Infection

  MAUDE report 50177247 ↗
• 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT.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 PROCEDURES PROVIDED IN MONTHLY REPORT OF (B)(6) 2026 DURING THE REVIEW OF THE REPORT, A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 25229665 ↗
• 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 24482306 ↗
• 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 24231993 ↗
• 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 24066790 ↗
• InjuryOct 28, 2025Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT, THE REVISION SURGERY WAS PERFORMED AND THE ASCEND FLEX/REVERSED II IMPLANTS WERE REVISED TO THE PERFORM REVERSE GLENOID IMPLANTS AS THE GLENOID IMPLANTS HAD MIGRATED SUPERIORLY. REVISION SURGERY WAS SUCCESSFULLY COMPLETED. IT WAS FURTHER REPORTED THAT, ALL GLENOID IMPLANTS WERE REMOVED (SUSPECTS), THE HUMERAL TRAY AND LINER WAS REMOVED (CONCOMITANTS). HUMERAL STEM REMAINED STABLE AND SO SURGEON LEFT IN SITU. NEW TRAY AND LINER AND GLENOID SYSTEM INSERTED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23405215 ↗
• InjuryJul 17, 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) 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. STAGE 1 OF 2 STAGE REVISION.

  Patient problems: Unspecified Infection

  MAUDE report 22529679 ↗
• InjuryJun 18, 2025Loss of Osseointegration; Loss of Osseointegration

  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 ASEPTIC LOOSENING GLENOID, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Osteolysis

  MAUDE report 22282928 ↗
• InjuryMay 20, 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 WITH THE TORNIER SHOULDER SYSTEM. THE REPORT DETAILS ANALYSIS PROVIDED FOR PROCEDURES PERFORMED BETWEEN DECEMBER 2013 ¿ FEBRUARY 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2023, A PATIENT REQUIRED REVISION SURGERY DUE TO PERIPROSTHETIC FRACTURE, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Bone Fracture(s)

  MAUDE report 22056066 ↗
• InjuryMay 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PHS STUDY SUBJECT: (B)(4). 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 21948038 ↗
• InjuryApr 22, 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 21882372 ↗
• InjuryFeb 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REVISION SURGERY WAS PLANNED TO BE PERFORMED ON (B)(6) 2024, USING THE BLUEPRINT PLANNING FEATURE (CASE ID: (B)(4)). THE PATIENT WAS REVISED DUE TO A FALL THAT KNOCKED THE BASEPLATE LOOSE.

  Patient problems: Fall

  MAUDE report 21334601 ↗
• InjuryDec 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE LOCKING MECHANISM CAME OFF WHEN SURGEON WAS TIGHTENING THE LOCKING SCREW. THE SURGEON TRIED TO RE-INSERT THE METAL RING INTO THE BASEPLATE BUT WAS UNABLE. SURGEON HAD TO REMOVE 3 PERIPHERAL SCREWS, CENTRAL SCREW AND BASEPLATE ALREADY IN PLACE AND PUT IN A NEW IMPLANT. THIS WAS A SECOND REVISION SURGERY FOR THE PATIENT. SURGEON HAD TO USE BONE GRAFT TO COMPENSATE FOR BONE LOST ON THE GLENOID SIDE WHEN REMOVING THE ORIGINAL BASEPLATE. MOST OF THE BONE GRAFT WAS LOST WHEN SURGEON HAD TO REMOVE THE DEFECTIVE BASEPLATE, DECREASING THE OCCURRENCE OF SUCCESSFUL BONE INTEGRATION.

  Patient problems: Failure of Implant

  MAUDE report 21018035 ↗
• InjuryNov 14, 2024Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  AS REPORTED: "PHS STUDY SUBJECT: (B)(6). COMPLICATION DESCRIPTION: INSTABILITY/DISLOCATION PATIENT HAS HAD CONTINUED INSTABILITY OF RIGHT RSA DESPITE FORMALIZED PT. PATIENT REVISED ON (B)(6) 2024."

  Patient problems: Joint Laxity; Subluxation

  MAUDE report 20681014 ↗
• InjuryOct 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT: "LOCKING RING INSIDE 29MM 15 DEGREE FULL WEDGE BASEPLATE (DWJ515) SN: (B)(6)". IT WAS REPORTED THAT DURING IMPLANTATION OF PERIPHERAL SCREWS, THE LOCKING RING IN THE BASEPLATE CAME LOOSE AND FELL OUT. THE SURGEON HAD TO USE ANOTHER BASEPLATE AFTER REMOVING DEFECTIVE ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20494761 ↗
• InjuryOct 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS SCHEDULED, USING THE BLUEPRINT PLANNING FEATURE . THE PATIENT DEVELOPED AN INFECTION, AND THE SURGEON REMOVED ALL IMPLANTS, INCLUDING TORNIER'S FLEX STEM AND PERFORM REVERSE GLENOID SYSTEMS, AND REPLACED THEM WITH AN ANTIBIOTIC SPACER. THERE WERE NO COMPLICATIONS IN REMOVING THE IMPLANTS AND PLACING THE ANTIBIOTIC SPACER.

  Patient problems: Unspecified Infection

  MAUDE report 20396091 ↗
• 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 19228480 ↗
• 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 18890749 ↗
• InjuryFeb 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF FAILED PERFORM REVERSE GLENOID BASEPLATE. PATIENT HAD SUDDEN ONSET OF PAIN AFTER PHYSICAL EXERTION. FAILURE OF GLENOID BASEPLATE FIXATION INTO GLENOID NECESSITATED REVISION SURGERY. THIS WAS REMOVAL OF THE GLENOID COMPONENTS AND CONVERSION OF THE HUMERAL COMPONENT TO A HEMI COMPONENT.

  Patient problems: Implant Pain

  MAUDE report 18676925 ↗
• InjuryMay 17, 2023Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD SUBJECTIVE INSTABILITY. PATIENT STATES FEELING THAT THE SHOULDER "POPPED OUT" AND HAS TO WAIT TO RESUME ACTIVITY.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 16950442 ↗
• InjuryJan 19, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SHOULDER INSTABILITY AND A SMALL CYST ON THE SHOULDER IN (B)(6) 2022. THE PATIENT PRESENTED FOR ULTRASOUND/BIOPSY ON (B)(6) 2022. ON (B)(6) 2022 POST OP INFECTION WAS CONFIRMED. THE PATIENT UNDERWENT A REVISION PROCEDURE TO EXPLANT THE SYSTEM AND REPLACE IT WITH A SPACER.

  Patient problems: Bacterial Infection; Cyst(s); Joint Laxity; Unspecified Infection

  MAUDE report 16210120 ↗
• InjuryDec 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED AN ACROMION STRESS FRACTURE. THE PATIENT HAS NOT NOTICED A DECREASE IN RANGE OF MOTION BUT HAS EXPERIENCED AN INCREASE IN PAIN.

  Patient problems: Bone Fracture(s); Loss of Range of Motion; Pain

  MAUDE report 15950539 ↗
• InjuryJul 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO AN INFECTION 12 MONTHS POST-OP. THE METAL DEVICES WERE REMOVED AND A COMPETITOR'S CEMENT SPACER WAS INSERTED.

  Patient problems: Unspecified Infection

  MAUDE report 15044094 ↗