Baseplate positioner/impactor 269903Recalls & reported problems
Fournitures Hospitalieres Industrie · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03661489699030), received between Feb 22, 2022 and Feb 22, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break2
Patient problems
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 22, 2022Break; Break
DURING THE INSTALLATION OF THE DEFINITIVE BASEPLATE, WHEN LOOSENING THE GLENOSPHERE POSITIONER/IMPACTOR FROM THE IMPLANT, THE CONNECTING BAR OF THE WHEEL BROKE OFF. THE INSTRUMENT IS IN 3 PARTS. THE THREADED BAR WAS STILL HOLDING THE BASEPLATE AND WE WERE ABLE TO REMOVE IT FROM THE IMPLANT AND FINISH THE IMPACTION.
Patient problems: Insufficient Information
MAUDE report 13578812 ↗MalfunctionFeb 22, 2022Break; Break
DURING THE INSTALLATION OF THE DEFINITIVE BASEPLATE, WHEN LOOSENING THE GLENOSPHERE POSITIONER/IMPACTOR FROM THE IMPLANT, THE CONNECTING BAR OF THE WHEEL BROKE OFF. THE INSTRUMENT IS IN 3 PARTS.
Patient problems: Insufficient Information
MAUDE report 13578800 ↗
Other Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented devices
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- Equinoxe 320-42-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-42-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls87 reports
- Equinoxe 320-38-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls43 reports
- Equinoxe 320-42-13Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls41 reports
- Equinoxe 320-10-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented132 reports
- Equinoxe 320-36-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls27 reports
- Equinoxe 320-42-10Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls14 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.