LCP 439.991Recalls & reported problems
Synthes GmbH · 4.5MM TI LCP® MEDIAL PROXIMAL TIBIA PLATE 10H/LEFT 214MM · Class 2 · Implant
All models of LCP (367)
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 10886982219886), received between Jan 12, 2023 and Jan 12, 2023 — classified as 1 injury.
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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Bone Fracture(s)1
- Impaired Healing1
- Inflammation1
- Loss of Range of Motion1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DEVICE REPORT FROM CHINA REPORTS AN EVENT AS FOLLOWS: POST-OP INFLAMMATION. THIS CASE IS FROM THE HEALTH AUTHORITY. IT WAS REPORTED THAT LAST MARCH, THE PATIENT SUFFERED A FRACTURE OF THE LEFT TIBIAL PLATEAU DUE TO TRAUMA AND WAS HOSPITALIZED FOR SURGICAL TREATMENT. THE EXISTING INTERNAL FIXATION WAS KEPT IN THE HOSPITAL. AFTER SURGERY, THE KNEE JOINT SUFFERED FROM PAIN AND DISCOMFORT. SIX MONTHS LATER, THE PATIENT WAS HOSPITALIZED FOR TREATMENT. AFTER SYMPTOMATIC TREATMENT, THE PATIENT WAS DISCHARGED. AFTER DISCHARGE, THE PATIENT COMPLAINED THAT THE PAIN HAD WORSENED, AND STILL COULD NOT WALK FOR A LONG TIME. THE PATIENT COULD BE RELIEVED BY LYING IN BED. NOW, THE SURGICAL HEALING SCAR AT THE PROXIMAL END OF THE LOWER LEG CAN BE SEEN; IN MAY OF THIS YEAR, THERE WAS NO OBVIOUS INDUCEMENT TO FIND A MASS IN THE FRONT OF THE MIDDLE SEGMENT OF THE LEFT CALF, ABOUT 3CM IN DIAMETER, WITH SLIGHT TENDERNESS. DUE TO LACK OF ATTENTION, THE PATIENT LATER COMPLAINED THAT THE MASS WAS GRADUALLY INCREASING, AND THE LEFT KNEE JOINT MOVEMENT WAS PARTIALLY LIMITED. HE WAS HOSPITALIZED IN THE LOCAL HOSPITAL FOUR MONTHS LATER, AND THE CULTURE OF PUNCTURE SECRETIONS SHOWED NEGATIVE. CONSIDERING THAT T
Patient problems: Bone Fracture(s); Impaired Healing; Inflammation; Loss of Range of Motion; Pain
MAUDE report 16148323 ↗
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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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