TORNIER PERFORM™ Patient-Matched DWJ603Recalls & reported problems
Tornier, Inc. · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00846832079483), received between Jan 19, 2023 and Jan 30, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Fracture1
- Migration1
Patient problems
- Failure of Implant1
- Inadequate Osseointegration1
- Loss of Range of Motion1
- Muscle Weakness/Atrophy1
- Nerve Damage1
- Paralysis1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 30, 2023Break; Fracture; Migration; Break; Fracture; Migration
REVISION NEED TO REMOVED FAILED IMPLANT AND CONVERT TO HEMI-ARTHROPLASTY.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 16268918 ↗InjuryJan 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT WAS SEEN ON FOR STANDARD OF CARE FOLLOW-UP VISIT. THE TREATING SURGEON DID NOT FEEL A STRONG CONTRACTION IN THE AXILLARY NERVE. PATIENT COULD NOT HOLD ARM IN ABDUCTION AGAINST GRAVITY. DELTOID CONTRACTION WAS MINIMAL. PATIENT WILL COMPLETE NORMAL PHYSICAL THERAPY PLAN.
Patient problems: Loss of Range of Motion; Muscle Weakness/Atrophy; Nerve Damage; Paralysis
MAUDE report 16210401 ↗
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- DELTA XTEND 130790030Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED132 reports
- DJO SURGICAL 509-00-436Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented124 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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