LCP 226.682Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982159342), received between May 21, 2019 and May 9, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Material Deformation” (1 report).

1 other recall cover devices cleared under the same FDA submission (K000682, K041911, K082807); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT #(B)(6) : 93-YEAR-OLD MALE WAS IMPLANTED WITH LCP BROAD, CURVED PLATES 4.5/5.0 (226.682) IN FEMUR WITH DPS SCREWS (UNKNOWN QUANTITY) WITH OTHER ADJUNCTIVE FIXATION DEVICES (2 CABLES (SYNTHES), FIBULAR STRUT). INTRA-OPERATIVE COMPLICATION: FRACTURE COMMINUTION EXPERIENCED INTRA-OP RELATED TO SYNTHES PROCEDURE. TREATMENT: SURGICAL TREATMENT FOR HARDWARE REMOVAL PERFORMED FOR REMOVAL OF ALL HARDWARE 12 WEEKS POST-OP. OUTCOME: UNKNOWN. THIS REPORT IS FOR A 4.5MM CURVED BROAD LCP® PLATE 18 HOLES/336MM. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 19280594 ↗
• InjuryAug 20, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON JULY 23, 2019, THE PATIENT UNDERWENT REVISION SURGERY DUE TO LOCKING COMPRESSION (LCP) CURVED PLATE THAT WAS BENT. A 4.5 LCP CURVED PLATE, UNKNOWN CABLES, AND UNKNOWN SCREWS WERE IMPLANTED ON (B)(6) 2015, VIA OPEN REDUCTION INTERNAL FIXATION (ORIF) OF A PERIPROSTHETIC FEMUR FRACTURE AT THE DISTAL TIP OF A HIP STEM. THE PATIENT FELL, AND THE PLATE BENT, CAUSING A REVISION SURGERY. THE ONE (1) LCP CURVED PLATE, ALONG WITH THREE (3) UNKNOWN CABLES AND SEVEN (7) UNKNOWN SCREWS OF UNKNOWN LENGTH WERE REMOVED, AND A 4.5 VARIABLE ANGLE-LOCKING COMPRESSION PLATE (VA-LCP) CURVED CONDYLAR PLATE WAS IMPLANTED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN CABLES (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 3), UNKNOWN SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 7). THIS REPORT IS FOR ONE (1) 4.5 MM CURVED BROAD LCP® PLATE 18 HOLES/336 MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8910595 ↗
• InjuryMay 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REMOVAL OF OSTEOSYNTHESIS MATERIAL AS PART OF A RECONSTRUCTIVE SURGERY PROGRAM THAT CONSISTS OF SEVERAL STAGES. THE DAY THAT THE PLATE WAS REMOVED, THE SECOND STAGE WAS BEING PERFORMED. THE PATIENT HAD A WIDE LOCKING COMPRESSION PLATE (LCP) WITH SIX (6) LOCKING SCREWS AND TWO (2) CORTICAL SCREWS. WHEN THE IMPLANTS WERE REMOVED, A METALLOSIS PROCESS WAS FOUND DURING THE REMOVAL LOCATED IN THE CONTACT ZONE BETWEEN THE PLATE AND THE CORTICAL SCREWS. THE PLATE WAS OXIDIZED ONLY IN THE HOLES THAT HAD CONTACT WITH THE CORTICAL SCREWS, WHICH SUGGESTS A DIFFERENCE IN THE COMPOSITION OF BOTH MATERIALS. IT WAS MENTIONED THAT THE PATIENT'S SOFT TISSUES THAT WERE IN CONTACT WITH THE METALLOSIS AREA OF THE PLATE PRESENTED A DARK GRAY COLOR AND DEBRIDEMENT WAS NECESSARY. THERE WAS NO INFECTION. THE PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. CONCOMITANT DEVICES: LOCKING SCREWS (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 6). THIS REPORT IS FOR A 4.5MM CURVED BROAD LCP®. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Toxicity

  MAUDE report 8628582 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K000682, K041911, K082807. One submission often covers many models, so check the product and lot details in each record.

• Z-0409-2014 · Jul 30, 2013 · Terminated
  Synthes 4.5 mm LCP Curved Condylar Plate Intended for buttressing multifragmentary distal femur fractures.