Tornier Perform® Reversed Augmented Glenoid DWJ502Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00846832092123), received between Mar 8, 2022 and Sep 18, 2026 — classified as 23 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Device Misassembled During Manufacturing /Shipping” (5 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 16, 2026.

Recalls naming this device

1. Sep 15, 2023Class IIOpen, Classified

   One lot of Tournier Perform Reversed Lateralized Baseplates were found to have been manufactured with 6mm spacers instead of 3mm spacers. This nonconformance prevents the central screw from being able to thread into the baseplate.

   Z-0113-2024 · Root cause: Process change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Device Dislodged or Dislocated

  Patient problems: Unspecified Infection

  MAUDE report 50820935 ↗
• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  THE CLAIMANT ALLEGES SHE SUSTAINED INJURIES DURING A SURGICAL PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 25050675 ↗
• MalfunctionMar 23, 2026Device Dislodged or Dislocated

  THE LOCKING OLIVE OF THE BASEPLATE WAS DISLODGED. THE SURGEON WAS UNABLE TO PUT LOCKING OLIVE BACK IN PLACE. AS A RESULT, A NEW BASEPLATE HAD TO BE OPENED WHICH CAUSED A 10 MINUTE SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24669040 ↗
• InjuryMar 10, 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT.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) 2025 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 24556884 ↗
• InjuryMar 10, 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 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) 2025 A PATIENT REQUIRED REVISION SURGERY DUE TO INSTABILITY, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Joint Laxity

  MAUDE report 24556759 ↗
• InjuryFeb 24, 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 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 INSTABILITY WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Joint Laxity

  MAUDE report 24428899 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  A PLANNED REVISION SURGERY WAS PERFORMED BY THE SURGEON USING THE BLUEPRINT PLANNING FEATURE. REASON FOR REVISION - SOFT TISSUE INTERPOSITION AND THE IMPLANT AND/OR IMPINGEMENT OF THE LESSER TUBEROSITY ON THE CORACOID.

  Patient problems: Joint Impingement; Pain

  MAUDE report 24303803 ↗
• InjuryNov 27, 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 ON (B)(6) 2024 A PATIENT REQUIRED REVISION SURGERY DUE TO ASEPTIC LOOSENING GLENOID, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Osteolysis

  MAUDE report 23665398 ↗
• InjuryOct 20, 2025Osseointegration Problem; Osseointegration 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 ASEPTIC LOOSENING GLENOID, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Osteolysis

  MAUDE report 23334679 ↗
• InjuryJul 9, 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) 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION & INSTABILITY, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. STAGE 1 OF 2 STAGE REVISION.

  Patient problems: Joint Laxity; Unspecified Infection

  MAUDE report 22456107 ↗
• InjuryJul 9, 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) 2025 A PATIENT REQUIRED REVISION SURGERY DUE TO PERIPROSTHETIC FRACTURE, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Bone Fracture(s)

  MAUDE report 22456031 ↗
• InjuryMay 27, 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 UNEXPLAINED PAIN, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Pain

  MAUDE report 22091780 ↗
• MalfunctionNov 14, 2024Positioning Failure; Detachment of Device or Device Component; Positioning Failure; Detachment of Device or Device Component

  THE SCREW WAS SPINNING AND WOULD NOT LOCK WHEN INSERTED INTO THE LOCKING SCREW HOLE IN THE BASE PLATE. IT WAS CONFIRMED THAT THE C-SHAPED RING IN THE LOCKING SCREW HOLE HAD SEPARATED FROM THE BASE PLATE AND WAS SPINNING. WHEN THE INSERTED SCREW WAS PULLED OUT, THE C-SHAPED RING PART WAS PULLED OUT WITH THE LOCKING PART OF THE SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20681887 ↗
• InjuryOct 22, 2024Component Missing; Component Missing

  IT WAS REPORTED THAT: SURGERY BEGAN AROUND 1:30 P.M. AFTER THE SKIN INCISION, IT WAS DISCOVERED THAT THE IMPLANT HAD NOT BEEN PREPARED. BECAUSE OF THE TIME REQUIRED FOR THE IMPLANT TO ARRIVE, THE WOUND WAS CLOSED ONCE AND THE INSTRUMENT RE-STERILIZED. THE SURGERY RESTARTED AT 22:38 AND FINISHED AROUND 23:45. THE WOUND WAS CLOSED ONCE THE SITUATION HAD PROGRESSED TO THE ARTHRODESIS AFTER THE HEAD OSTEOTOMY. UPON RETURNING TO THE PATIENT'S ROOM, THE PATIENT COMPLAINED OF PAIN.

  Patient problems: Pain

  MAUDE report 20510746 ↗
• InjuryAug 22, 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) 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 20039782 ↗
• InjuryMar 23, 2024Biocompatibility; Biocompatibility

  THE PATIENT REPORTED PAIN AND DECREASED FUNCTION, LEADING TO A REVISION SURGERY. THE REASON FOR THE REVISION SURGERY WAS LISTED AS HETEROTOPIC OSSIFICATION, SEVERE STIFFNESS, AND NICKEL METAL ALLERGY. COMPONENTS INCLUDING THE TRAY, INSERT, AND GLENOSPHERE WERE EXPLANTED, WHILE THE STEM, BASEPLATE, AND CENTRAL SCREW WERE RETAINED. THE RELATEDNESS TO THE STUDY DEVICE AND THE SURGICAL PROCEDURE WAS ASSESSED AS POSSIBLE.

  Patient problems: Extraskeletal ossification; Implant Pain; Loss of Range of Motion; Metal Related Pathology

  MAUDE report 18965675 ↗
• MalfunctionMar 23, 2024Positioning Failure; Positioning Failure

  AN ISSUE AROSE WITH A BASEPLATE WHERE THE CENTRAL SCREW WOULDN'T FULLY ENGAGE. FORTUNATELY, THIS DIDN'T AFFECT THE PATIENT OR SURGERY DUE TO HAVING A BACKUP AVAILABLE. THE INCIDENT OCCURRED DURING A PRIMARY REVERSE SURGERY. THERE WAS A BRIEF DELAY TO RESOLVE THE ISSUE AND OBTAIN ANOTHER BASEPLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18965631 ↗
• InjuryMar 5, 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) 2018 A PATIENT REQUIRED REVISION SURGERY DUE TO PERIPROSTHETIC FRACTURE, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Limb Fracture

  MAUDE report 18842024 ↗
• 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 18681620 ↗
• 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 18681612 ↗
• InjuryNov 7, 2023Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  A PATIENT PRESENTED WITH SHOULDER PAIN EXACERBATED BY LYING ON THE LEFT SIDE. INITIAL X-RAYS WERE INCONCLUSIVE BUT INDICATED A SUSPECTED STRESS REACTION DUE TO DELTOID TENSION. A BONE SCAN ON A LATER DATE, CONFIRMED AN ACROMIAL STRESS REACTION. TREATMENT INVOLVED SIX WEEKS OF SLING USE FOLLOWED BY PHYSICAL THERAPY (PT), WHICH DID NOT ALLEVIATE SYMPTOMS. ANOTHER BONE SCAN ON THE SAME DAY CONFIRMED AN ACROMIAL STRESS FRACTURE. PT CONTINUED, SUPPLEMENTED BY A PLATELET-RICH PLASMA (PRP) INJECTION TO THE DELTOID. THE ADVERSE EVENT RESOLVED WITHOUT FURTHER ISSUES.

  Patient problems: Bone Fracture(s); Implant Pain; Joint Laxity; Subluxation

  MAUDE report 18086828 ↗
• InjuryOct 25, 2023Migration; Migration

  A REVISION SURGERY WAS CONDUCTED USING THE BLUEPRINT PLANNING FEATURE. DURING THE SURGERY, TORNIER PRODUCTS, SPECIFICALLY A 36 GLENOSPHERE AND A 25+3 BASEPLATE, WERE REMOVED. THIS REVISION SURGERY WAS NECESSITATED BY A FALL AND THE SUBSEQUENT MIGRATION OF THE BASEPLATE.

  Patient problems: Fall

  MAUDE report 18007110 ↗
• MalfunctionSep 14, 2023Mechanical Problem; Device Misassembled During Manufacturing /Shipping; Mechanical Problem; Device Misassembled During Manufacturing /Shipping

  DURING THE PATIENT'S PROCEDURE, THE SURGEON ATTEMPTED TO INSERT A 6.5 CENTER SCREW INTO THE BASEPLATE, BUT IT GOT STUCK ON THE INNER THREADS OF THE BASEPLATE, PREVENTING IT FROM ADVANCING TO THE CORRECT POSITION. TRYING A DIFFERENT SCREW YIELDED THE SAME RESULTS. SUBSEQUENTLY, THE SURGEON OPENED A NEW BASEPLATE, AND WITHOUT ANY ISSUES, THE SCREW PROPERLY ENGAGED WITH THE BASEPLATE. THIS EVENT OCCURRED DURING A PRIMARY SURGERY. THERE WAS NO DEBRIS REPORTED, AND IF ANY HAD BEEN PRESENT, IT WAS SUCCESSFULLY REMOVED FROM THE SURGICAL FIELD OR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17750367 ↗
• MalfunctionSep 14, 2023Device Difficult to Setup or Prepare; Mechanical Jam; Device Difficult to Setup or Prepare; Mechanical Jam

  THE BASEPLATE INITIALLY COULDN'T ACCOMMODATE THE CENTER COMPRESSION SCREW. EFFORTS WERE MADE TO RESET THE SPACER, BUT IT DIDN'T WORK WITH THE T20 DRIVER OR A LONG-HANDLED SCREWDRIVER. AFTER MULTIPLE UNSUCCESSFUL ATTEMPTS, AN ALTERNATIVE BASEPLATE WAS USED. THE REPORTER ATTEMPTED TO RESET THE SPACER AFTER THE PROCEDURE BUT COULDN'T GET THE SCREW TO FIT PROPERLY. IT'S BELIEVED THAT THE SPACER IN THE BASEPLATE WAS MEANT FOR A +6MM BASEPLATE. THE ISSUE HAPPENED DURING A PRIMARY REVERSE, INVOLVING A 6.5 30 SCREW (DWJ130), AND IT WAS ULTIMATELY RESOLVED BY SWITCHING TO A DIFFERENT BASEPLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17750366 ↗
• MalfunctionSep 14, 2023Mechanical Problem; Device Misassembled During Manufacturing /Shipping; Mechanical Problem; Device Misassembled During Manufacturing /Shipping

  THE PHYSICIAN ATTEMPTED TO INSERT THE CENTER SCREW INTO THE BASEPLATE, BUT IT WOULDN'T ADVANCE. TRYING A DIFFERENT SCREW HAD THE SAME RESULT. EVENTUALLY, A NEW BASEPLATE WAS USED, AND IT WORKED WITHOUT ANY ISSUES. THE PROCEDURE, WHICH INVOLVED REVERSE CENTRAL SCREW, PERIPHERAL SCREWS, AND GLENOSPHERE, WAS PLANNED WITH THE PROBLEMATIC BASEPLATE, BUT IT COULDN'T BE USED BECAUSE THE CENTRAL SCREW COULDN'T BE THREADED ALL THE WAY INTO THE BASEPLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17750365 ↗