MAUDE Adverse Event Report: SYNTHES MEZZOVICO 4.5MM VA-LCP CURVED CONDYLAR PLATE/12 HOLE/266MM/LEFT; IMPLANT, FIXATION DEVICE CONDYLAR PLATES

Catalog Number 02.124.413

Device Problem Fitting Problem (2183)

Patient Problems Fall (1848); Failure of Implant (1924)

Event Date 11/23/2015

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: patient weight not provided by reporter.Additional product codes: hrs, hwc.Device is not expected to be returned for manufacturer review/investigation.Device history records was conducted.The report indicates that: art number: 02.124.413, lot : 8671432, manufacturing location: (b)(4), manufacturing date: 16.Oct.2013, no anomalies were detected during device history record review.No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that a distal femur revision surgery was performed on (b)(6) 2015 after the patient fell while in rehab and the screws were noted to back out from the plate.During the revision one (1) plate and thirteen (13) screws (4 locking and 9 cortex) were explanted intact and a new plate and screws were implanted.There was confirmed no broken hardware noted.The procedure was successfully completed with no additional intervention, patient harm or surgical delay.No x-rays will be available.This report is 1 of 3 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/12 HOLE/266MM/LEFT
• Type of Device: IMPLANT, FIXATION DEVICE CONDYLAR PLATES
• Manufacturer (Section D): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• Manufacturer (Section G): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5292828
• MDR Text Key: 33384663
• Report Number: 1000562954-2015-10216
• Device Sequence Number: 1
• Product Code: JDP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK110354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.413
• Device Lot Number: 8671432
• Other Device ID Number: (01)10886982042873(10)8671432
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR