Tornier Perform® Anatomic Glenoid DWE503Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03700434019186), received between Jun 8, 2022 and Aug 13, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 13, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES WITH THE TORNIER SHOULDER SYSTEM.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) 2019 A PATIENT REQUIRED REVISION SURGERY DUE TO DISLOCATION/SUBLUXATION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Joint Dislocation

  MAUDE report 17537967 ↗
• InjuryJan 6, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THERE WAS A PATIENT UNDERWENT A TOTAL SHOULDER REPLACEMENT. DURING SURGERY, SURGEON NOTED THAT A TENDONOUS TEAR OF THE JUNCTION OF THE SUPRASPINATUS AND SUBSCAPULARIS TENDONS EXISTED. SURGEON PERFORMED A REPAIR USING ANCHORS. POST-OP REHABILITATION PROCEEDED WITHOUT INCIDENT. HOWEVER, SEVERAL MONTHS FOLLOWING PRIMARY SURGERY, PATIENT COMPLAINED OF INCREASING PAIN, SWELLING AND INSTABILITY OF SHOULDER JOINT. SURGEON PERFORMED A SHOULDER ARTHROSCOPY, TO DISCOVER FULL THICKNESS TEARS OF BOTH OF THE AFORE MENTIONED TENDONS. DISCUSSED WITH THE PATIENT, WHERE A DECISION WAS MADE TO CONVERT THE SURGERY TO A REVERSE SHOULDER REPLACEMENT. DURING SURGERY TODAY, BOTH HUMERAL AND GLENOID COMPONENTS WERE REMOVED, AS PER THE RECOMMENDED SURGICAL TECHNIQUE. THE SURGEON HAS NO EXPLANATION AS TO WHY THE PATIENT'S ROTATOR CUFF TENDONS DETERIORATED IN SUCH A SHORT PERIOD OF TIME, RENDERING THE PROSTHETIC JOINT UNSTABLE, OTHER THAN HIS BELIEF THAT MICROSCOPIC POLY DEBRIS MAY HAVE SET UP AN INFLAMMATORY LOCAL RESPONSE THAT INHIBITED THE TENDON TEAR TO HEAL. ALL COMPONENTS DISCARDED.

  Patient problems: Failure of Implant; Foreign Body In Patient; Implant Pain; Swelling/ Edema

  MAUDE report 16118410 ↗
• InjuryJun 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT NOTICED PAIN AFTER PHYSICAL THERAPY POST-OPERATIVE ROTATOR CUFF TEAR . THE MRI SHOWS A LESSER TUBEROSITY AVULSION AND SUBSCAPULARIS TEAR. THE PATIENT UNDERWENT AN OPEN ROTATOR CUFF REPAIR WITH SUPERIOR CUFF RECONSTRUCTION USING ARTHOFLEX ALLOGRAFT. THE EVENT WAS RESOLVED WITHOUT SEQUELAE.

  Patient problems: Implant Pain; Muscle/Tendon Damage

  MAUDE report 14633198 ↗