NA 02.221.114SRecalls & reported problems
Synthes GmbH · 3.5/4.5MM VA PPFX PROX FEMUR PLATE/8HOLES/RIGHT/STERILE · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982275882), received between Aug 24, 2026 and Aug 24, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Migration” (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
Most reported problems
Device problems
- Migration1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 24, 2026Migration
Subject ID: (b)(6)Study No: No information provided.Clinical Adverse Event received for Fixation Failure (displacement of fixation) with specifically: Displacement of screws, Displacement of plate, Breakage of screw(s)Device related: YesProcedure related: YesDate of Event: 29-Jun-2026.Date of Implant: (b)(6)2025.Date of Revision: (b)(6) 2026.Device Location: Distal femur.Treatment/Impact: infection at the time of the periprosthetic plate placement (2025 (b)(6)), Resulted in medical or surgical intervention: YES, Required in-patient hospitalization or prolongation of existing hospitalization: YES, resulted in a permanent impairment of a body structure or function: YES, 2-stage surgery - OSME (which means Osteosynthesis Material Extraction--meaning, removal of the failed plate and screws) + explantation TKR + spacer on (b)(6) 2026, second stage surgery planned for (b)(6) 2026.DePuy Synthes Products Used:Catalog Number: No information provided.Lot Number: No information provided.Component Type: PLATEDescription: No information provided.Catalog Number: No information provided.Lot Number: No information provided.Component Type: SCREWDescription: No information provided.Catalog Number: N
Patient problems: Insufficient Information
MAUDE report 50412054 ↗
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- PRECICE® Plating System LP4.5-DRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls1 report
- PRECICE® Plating System LP4.5-PLF40Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
- PRECICE® Plating System LP4.5-PRT42Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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