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TORNIER PERFORM™ REVERSED DWJ1017301Recalls & reported problems

Tornier, Inc. · Class 2 · Implant

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
7
Deaths reported
0
Injuries reported
7
Recalls naming it
0

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00846832085644), received between Jul 25, 2024 and Nov 25, 2025 — classified as 7 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 1 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 1 reportsJan 2025: 2 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 1 reportsNov 2025: 2 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem5
  • Device Dislodged or Dislocated1
  • Loss of Osseointegration1

Patient problems

  • Bone Fracture(s)3
  • Implant Pain2
  • Fever1
  • Inadequate Osseointegration1
  • Joint Dislocation1
  • Joint Impingement1
  • Pain1

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

  • InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    SUBJECT: (B)(6) SHOULDER ID STUDY. SCAPULAR FRACTURE - ACROMIAL. PT BEGAN EXPERIENCING SEVERE LEFT SHOULDER PAIN STARTING AROUND (B)(6) 2025. CT COMPLETED ON (B)(6) 2025 SHOWED MINIMALLY DISPLACED FRACTURE OF THE ACROMION.

    Patient problems: Bone Fracture(s); Pain

    MAUDE report 23642358 ↗
  • InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A REVISION SURGERY WAS PERFORMED DUE TO AN ACROMIAL STRESS FRACTURE.

    Patient problems: Bone Fracture(s)

    MAUDE report 23578124 ↗
  • InjuryOct 15, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

    SUBJECT: (B)(6). SHOULDER ID STUDY. (B)(6) 2025. INSTABILITY, ANTERIOR DISLOCATION. PATIENT WAS FOUND TO HAVE A POST-OPERATIVE ANTERIOR SHOULDER DISLOCATION UPON X-RAY AT INITIAL POST-OPERATIVE VISIT. SHE WAS REVISED ON (B)(6) 2025.

    Patient problems: Joint Dislocation

    MAUDE report 23301016 ↗
  • InjuryJan 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    AS REPORTED: "SUBJECT: (B)(6). PT BEGAN EXPERIENCING CONSTANT SEVERE SHOULDER PAIN ON (B)(6) 2024. CT UNREMARKABLE. AS OF (B)(6) 2024. PATIENT STILL IS EXPERIENCING SHOULDER PAIN, BUT NO LONGER AS CONSTANT OR SEVERE."

    Patient problems: Implant Pain

    MAUDE report 21262258 ↗
  • InjuryJan 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    AS REPORTED: "SUBJECT: 003-011 SHOULDER ID STUDY. SCAPULAR FRACTURE - SCAPULAR SPINE (POST-OPERATIVE)".

    Patient problems: Bone Fracture(s)

    MAUDE report 21147065 ↗
  • InjuryDec 20, 2024Loss of Osseointegration; Loss of Osseointegration

    IT WAS REPORTED THAT A REVISION SURGERY WAS PLANNED TO BE PERFORMED ON (B)(6) 2024, USING THE BLUEPRINT PLANNING FEATURE (CASE ID: (B)(4). THE POST OP X-RAYS SHOWED THE BASEPLATE WAS NOT SEATED. THE INITIAL BASEPLATE WAS REMOVED AND A NEW BASEPLATE AND GLENOSPHERE WERE IMPLANTED SUCCESSFULLY.

    Patient problems: Inadequate Osseointegration

    MAUDE report 20995242 ↗
  • InjuryJul 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    SUBJECT: (B)(6). SHOULDER ID STUDY. AS REPORTED: PATIENT REPORTED A "CATCHING" FEELING IN SHOULDER WITH INCREASED PAIN SINCE (B)(6) 2024. PT ALSO HAD A FEVER ON (B)(6) 2024; ANTIBIOTICS WERE PRESCRIBED FOR THIS. AS OF (B)(6) 2024, THE PATIENT REPORTED THAT HER SHOULDER PAIN IS IMPROVING.

    Patient problems: Fever; Implant Pain; Joint Impingement

    MAUDE report 19833647 ↗

Other PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED devices

All PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED devices →

Sources and updates

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