LCP 422.258SRecalls & reported problems
Synthes GmbH · TI LCP DISTAL FEMUR PLATE 13 HOLES/316MM/RIGHT-STERILE · 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 10886982215499), received between Mar 5, 2024 and Mar 5, 2024 — 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Bone Fracture(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A THA ON THE LEFT SIDE. THE PRODUCTS USED FOR THE THA WERE FROM A COMPETITOR. AFTER THE THA, A PERIPROSTHETIC FRACTURE OCCURRED AND A REOPERATION WAS PERFORMED ON (B)(6) 2020 WITH THE PLATE AND LOCKING SCREWS IN QUESTION. AFTER THE REOPERATION, A SUPRACONDYLAR FRACTURE OF THE LEFT FEMUR OCCURRED, AND A SECOND REOPERATION WAS PERFORMED ON (B)(6) 2024. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TI LCP DISTAL FEMUR PLATE 13 HOLES/316MM/RIGHT-STERILE. THIS IS REPORT 1 OF 4 FOR (B)(4).
Patient problems: Bone Fracture(s)
MAUDE report 18837522 ↗
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- PRECICE® Plating System LP4.5-MLT4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls5 reports
- PRECICE® Plating System LP4.5-PLF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls3 reports
- PRECICE® Plating System LP4.5-MRT4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls3 reports
- 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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