INVISION 60012004Recalls & reported problems
Wright Medical Technology, 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 00840420193957), received between Mar 15, 2022 and Apr 23, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Osseointegration Problem” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Appropriate Device Problem Term/Code Not Available1
- Osseointegration Problem1
- Unintended Movement1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Cyst(s)1
- Damage to Ligament(s)1
- Inadequate Osseointegration1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 23, 2025Osseointegration Problem; Unintended Movement; Osseointegration Problem; Unintended Movement
IT WAS REPORTED THAT A REVISION SURGERY IS NEEDED DUE TO TALUS COMPONENT SCREWS¿ BREAKAGE. THE EXISTING TIBIA COMPONENT WILL REMAIN IN SITU. IT WAS ALSO REPORTED THAT THE PATIENT HAD: "NO PAIN AND EXCELLENT MOBILITY FOR A YEAR, FOLLOWED BY SUDDEN ONSET OF PAIN WHILE WALKING WITH A FEELING OF BREAKING. SINCE THEN, PAIN WHEN LOADING ESPECIALLY IN THE SUBTALAR REGION." ADDITIONALLY: "REVISION HISTORY: NO REVISION OF THE TALUS WAS PERFORMED BUT A FIRST IMPLANT DUE TO A LARGE TALAR CYST."
Patient problems: Cyst(s); Inadequate Osseointegration; Pain
MAUDE report 21894316 ↗InjuryMar 15, 2022Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY TO REMOVE THE HARDWARE AND TO PERFORM A TENDON LENGTHENING OF THE MIDFOOT; REARFOOT OR ANKLE ANKLE-TOTAL ANKLE ARTHROPLASTY; ANKLE-RECONSTRUCTION OF ANKLE LIGAMENT WITH GRAFT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Damage to Ligament(s)
MAUDE report 13776086 ↗
Other PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER devices
- Vantage 350-22-03Exactech, Inc. · Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer2 recalls2 reports
- Vantage 350-21-04Exactech, Inc. · Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer2 recalls0 reports
- INFINITY 33630023Wright Medical Technology, Inc. · PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER60 reports
- INFINITY 33600020Wright Medical Technology, Inc. · PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall9 reports
- Vantage 350-22-02Exactech, Inc. · Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer1 recall5 reports
- INFINITY 33650003Wright Medical Technology, Inc. · PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER55 reports
- INFINITY 33630022Wright Medical Technology, Inc. · PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER54 reports
- Vantage 350-21-02Exactech, Inc. · Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer1 recall4 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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