Tornier Perform® Reversed Glenoid DWJ014Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00846832090358), received between Jul 18, 2022 and Sep 18, 2026 — classified as 33 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 33 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  The manufacturer received a report from the National Joint Registry that contains unpublished collected data on the usage and the outcomes of the shoulder joint replacement.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 50820936 ↗
• InjurySep 18, 2026Device Dislodged or Dislocated

  Patient problems: Osteolysis; Subluxation

  MAUDE report 50819508 ↗
• 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 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 50790942 ↗
• InjuryAug 24, 2026Inadequacy of Device Shape and/or Size; Osseointegration Problem

  The patient underwent revision surgery due to painful hardware and a suspected loose baseplate.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 50412879 ↗
• 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 APRIL 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 25229460 ↗
• 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 APRIL 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 25229275 ↗
• InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT: (B)(6). SHOULDER ID STUDY. NARRATIVE: PATIENT CALLED THE CLINIC TO REPORT PAIN AND A POTENTIAL SHOULDER DISLOCATION. HE STATES HE RAISED HIS ARM OVERHEAD TOO QUICKLY. AFTER SEEING THE PATIENT, THE SURGEON REPORTED BEING CONCERNED FOR EITHER A DELTOID STRAIN OR ACROMIAL STRESS FRACTURE. THE SURGEON ADVISED THE PATIENT TO REST AND RETURN TO THE CLINIC IN TWO WEEKS WITH NEW IMAGES, AND SHE WILL FURTHER ASSESS HIM AT THAT TIME.

  Patient problems: Muscle/Tendon Damage; Pain

  MAUDE report 24637892 ↗
• InjuryFeb 16, 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) 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 24342210 ↗
• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT: (B)(6). SHOULDER ID STUDY. PATIENT RETURNED FOR NEW ONSET OF SHOULDER PAIN, LEFT SHOULDER. PAIN STARTED AFTER 3 MONTH FOLLOW-UP AND WAS SIGNIFICANTLY WORSE ON (B)(6) 2025. UNCLEAR DIAGNOSIS AT TIME OF VISIT AND PATIENT WILL UNDERGO CT FOR FURTHER ASSESSMENT.

  Patient problems: Pain

  MAUDE report 24198264 ↗
• InjuryJan 28, 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) 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2023, A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 24197670 ↗
• InjuryDec 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 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 23768672 ↗
• 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 23550355 ↗
• InjuryOct 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 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 23334517 ↗
• InjuryOct 3, 2025Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO PATIENT'S SHOULDER BEING UNSTABLE FOR APPROXIMATELY TWO MONTHS. TISSUE CULTURES AND A FROZEN SPECIMEN WERE COLLECTED AND SHOWED NO BACTERIAL GROWTH. THE INSTABILITY AND FREQUENT DISLOCATIONS HAD RESULTED IN WEAR OF THE +0 THICKNESS POLY. POSTOPERATIVELY, THE SHOULDER WAS REDUCED AND STABLE.

  Patient problems: Insufficient Information

  MAUDE report 23213594 ↗
• InjuryMay 26, 2025Unstable; Unstable

  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 INSTABILITY AND DISLOCATION/SUBLUXATION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Subluxation

  MAUDE report 22084123 ↗
• InjuryMay 15, 2025Migration; Migration

  PATIENT UNDERWENT RIGHT REVERSE SHOULDER REPLACEMENT ON (B)(6) 2025. OVER RECENT WEEKS, PATIENT HAS DISLOCATED THEIR PROSTHETIC SHOULDER JOINT TWICE, DURING ABDUCTION AND EXTERNAL ROTATION. PATIENT UNDERWENT SHOULDER CT, AND REVIEWED BY SURGEON, WHO SUSPECTED SOME BONEY OR SOFT TISSUE IMPINGEMENT WAS CAUSING THE JOINT INSTABILITY, THOUGH CT LOOKED UNREMARKABLE. DURING SURGERY THERE WERE SOME BONEY PROJECTIONS ON THE POSTERIOR HUMERAL HEAD FOUND, & SUBSEQUENTLY REMOVED, PLUS SOME EXCESS POSTERIOR CAPSULE, ALSO REMOVED. JOINT LAXITY ALSO NOTED. THE PRIMARY POLY, OFFSET TRAY REMOVED; PRIMARY IMPLANTED PERFORM REVERSE GLENOSPHERE REMOVED, AND REPLACED BY ECCENTRIC GLENOSPHERE. SURGEON ALSO IMPLANTED A TRAY AND POL. JOINT WAS FOUND TO BE STABLE, FULL RANGE OF MOTION DEMONSTRATED WITHOUT DISLOCATION. WOUND CLOSED.

  Patient problems: Joint Dislocation; Joint Impingement; Joint Laxity

  MAUDE report 22028422 ↗
• InjuryMay 15, 2025Migration; Migration

  PATIENT UNDERWENT RIGHT REVERSE SHOULDER REPLACEMENT ON (B)(6) 2025. OVER RECENT WEEKS, PATIENT HAS DISLOCATED THEIR PROSTHETIC SHOULDER JOINT TWICE, DURING ABDUCTION AND EXTERNAL ROTATION. PATIENT UNDERWENT SHOULDER CT, AND REVIEWED BY SURGEON, WHO SUSPECTED SOME BONEY OR SOFT TISSUE IMPINGEMENT WAS CAUSING THE JOINT INSTABILITY, THOUGH CT LOOKED UNREMARKABLE. DURING SURGERY THERE WERE SOME BONEY PROJECTIONS ON THE POSTERIOR HUMERAL HEAD FOUND, & SUBSEQUENTLY REMOVED, PLUS SOME EXCESS POSTERIOR CAPSULE, ALSO REMOVED. JOINT LAXITY ALSO NOTED. THE PRIMARY POLY, OFFSET TRAY REMOVED; PRIMARY IMPLANTED PERFORM REVERSE GLENOSPHERE REMOVED, AND REPLACED BY ECCENTRIC GLENOSPHERE. SURGEON ALSO IMPLANTED A TRAY AND POL. JOINT WAS FOUND TO BE STABLE, FULL RANGE OF MOTION DEMONSTRATED WITHOUT DISLOCATION. WOUND CLOSED.

  Patient problems: Joint Dislocation; Joint Impingement; Joint Laxity

  MAUDE report 22028309 ↗
• InjuryMar 12, 2025Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  REVISION OF PERFORM HUMERAL STEM AND PERFORM REVERSE GLENOID DONE IN USA FOR CHRONIC DISLOCATION (INSTABILITY). THE STANDARD GLENOSPHERE WAS EXCHANGE AND THE SYMMETRIC LINER WAS EXCHANGED, REDUCED AND CLOSED.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 21582872 ↗
• InjuryJan 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "EXPLANT RIGHT RSA WITH PLACEMENT OF ANTIBIOTIC CEMENT SPACER FOR INFECTION." THE SHOULDER HAD BEEN DRAINING PUSS FOR A LONG TIME.

  Patient problems: Unspecified Infection

  MAUDE report 21208419 ↗
• InjurySep 12, 2024Adverse 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 (B)(6) 2012 ¿ (B)(6) 2022. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2022 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. REVISION PROCEDURE TYPE: DEBRIDEMENT AND IMPLANT RETENTION (DAIR).

  Patient problems: Unspecified Infection

  MAUDE report 20201303 ↗
• InjuryAug 6, 2024Adverse 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 APRIL 2012 ¿ MAY 2022. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2020 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. REVISION PROCEDURE TYPE: STAGE 1 OF 2 STAGE REVISION.

  Patient problems: Unspecified Infection

  MAUDE report 19919041 ↗
• InjuryJul 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PT UNDERWENT PRIMARY RIGHT REVERSE SHOULDER REPLACEMENT, ON 19.2.2024. PT EXPERIENCED RECENT HISTORY OF PAIN, SWELLING, IN RIGHT PROSTHETIC SHOULDER JOINT. UNDERWENT REVISION ON (B)(6) 2024. MULTIPLE SPECIMENS TAKEN, TO DETERMINE IF INFECTION PRESENT - GLENOID COMPONENT, AND HUMERAL TRAY AND POLY REVISED. PT UNDERWENT A 2ND REVISION, ON (B)(6), DUE TO SIGNIFICANT SWELLING IN PROSTHETIC JOINT. WOUND OPENED, TO REVEAL LARGE COLLECTION OF HEMATOMA. NO OBVIOUS COLLECTION OF PUS. HUMERAL TRAY / POLY AGAIN REVISED, AS WELL AS THE GLENOSPHERE. MULTIPLE SPECIMENS AGAIN TAKEN. COPIOUS LAVAGE".

  Patient problems: Hematoma; Implant Pain; Swelling/ Edema

  MAUDE report 19722532 ↗
• 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 19235110 ↗
• InjuryApr 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PHONE CALL, A CASE OF REVISION SURGERY FOR A JOINT INFECTION RELATED TO INSTRUMENT BREAKAGE WAS DISCUSSED. THE BROKEN INSTRUMENT, IDENTIFIED AS A SCREWDRIVER, FRACTURED DURING A REVERSE SHOULDER REVISION SURGERY. THE PROCEDURE INVOLVED SUCCESSFULLY IMPLANTING A DEPUY SPACER. THE INFECTION WAS DETECTED THROUGH A SUPERFICIAL RASH NEAR THE INCISION SITE. MICROORGANISMS WERE NOT IDENTIFIED, AND IT'S UNCERTAIN IF THE PATIENT HAD A PRE-EXISTING INFECTION. NO STERILE IMPLANTS WERE OPENED DURING THE SURGERY, AND NO RE-STERILIZATION OF THE DEVICE WAS PERFORMED BEFORE THE SURGERY.

  Patient problems: Unspecified Infection

  MAUDE report 19012813 ↗
• InjuryFeb 13, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IN THIS CASE, A REVISION OF STRYKER IMPLANTS WAS PERFORMED, INVOLVING THE REVISION OF BOTH THE GLENOID SPHERE AND HUMERAL INSERT. THE ORIGINAL X-RAY, KNOWN AS THE FLUORO, WAS UTILIZED. TWO WEEKS POST-OPERATION, THERE WAS A REVISION TO 42 CENTERED, FOLLOWED BY A DISLOCATION OF 42 CENTERED, LEADING TO A REVISED SPHERE TO 42 ECCENTRIC AND 10-DEGREE POLY. THE SURGERIES WERE PLANNED WITH BLUEPRINT. DESPITE THE PATIENT'S HISTORY OF SCHIZOPHRENIA AND CHRONIC ANTERIOR DISLOCATION, NECESSITATING MULTIPLE REVISIONS, THERE WERE NO REPORTED ISSUES WITH THE IMPLANTS THEMSELVES.

  Patient problems: Joint Dislocation

  MAUDE report 18696385 ↗