|
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Bone Fracture(s) (1870); Unspecified Infection (1930); Impaired Healing (2378); No Code Available (3191)
|
Event Date 02/07/2017 |
Event Type
Injury
|
Manufacturer Narrative
|
This report is for an unknown 4.5mm variable angle locking compression plating system.Unknown part number, udi unavailable.(b)(6).The investigation could not be completed and no conclusion could be drawn, as no device was returned and no lot number or part number was provided.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
Literature article received: "this report is being filed after the subsequent review of the following literature article: poole, w.Et al (2017).Modern distal femoral locking plates allow safe, early weight-bearing with a high rate of union and low rate of failure.The bone & joint journal, vol 99-b, 951-957.(b)(6).This is a retrospective review of patients treated with a lateral distal femoral locking plate (ldflp) between 2009 and 2014 to describe the outcomes of fixation using modern implants within a strategy of early return to function.The study population included 122 patients (and a total number of 127 fractures).Patients (92 female) had a mean age of 72.8 years (range 16 to 101).107 patients were allowed to bear full weight immediately.The rate of clinical and radiological union was 81-85 (95%).Of the 127 patients: one patient underwent a re-operation for infection but revision fixation was not required, the metal work was retained until union.One patient underwent a re-operation for infection but revision fixation was not required, the metal work was retained until union; but subsequently removed.Six patients had symptomatic metalwork removed.Three patients underwent a reoperation for a fracture above the femoral plate, all after successful union of the primary fracture.This is report 5 of 5 for (b)(4).This is for an unknown 4.5mm variable angle locking compression plating system and refers to the serious injury one patient underwent a re-operation for infection but revision fixation was not required, the metal work was retained until union.One patient underwent a re-operation for infection but revision fixation was not required, the metal work was retained until union; but subsequently removed.Six patients had symptomatic metalwork removed.Three patients underwent a reoperation for a fracture above the femoral plate, all after successful union of the primary fracture.This report is for 1 device.
|
|
Manufacturer Narrative
|
Device was used for treatment, not diagnosis.Other relevant history, including preexisting medical conditions.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Manufacturer Narrative
|
Device was used for treatment not diagnosis.(b)(6).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Search Alerts/Recalls
|
|
|