MAUDE Adverse Event Report: SYNTHES USA 4.5MM VA-LCP CURVED CONDYLAR PLATE/14 HOLE/301MM/LEFT; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE

Catalog Number 02.124.415

Device Problem Break (1069)

Patient Problems Fall (1848); Pain (1994); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

Patient weight reported as (b)(6).Date of event: unknown.Implant date: unknown date (b)(6) 2014.Without a lot number, the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.

Event Description

It was reported that a revision surgery was performed on (b)(6) 2015 on a left femur fracture with a broken 14 hole, 4.5mm variable angle locking compression plate (lcp) curved condylar plate.On (b)(6) 2015, a female patient fell and injured her knee on a table.She went to her doctor and complained of pain and discomfort.X-rays revealed that the 14 holes, 4.5mm variable angle lcp curved condylar plate was broken at the fracture.The surgeon planned on removing the plate, eight (8) 5 mm cannulated locking screws and one (1) 4.5 cortex screw.Another 14 holes, 4.5mm variable angle lcp curved condylar plate was the planned revision implant.The original date of the implant was approximately (b)(6) 2014.Status of patient and outcome of revision surgery remain unknown.This is report 1 of 1 for (b)(4).

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/14 HOLE/301MM/LEFT
• Type of Device: IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5305643
• MDR Text Key: 33724412
• Report Number: 2520274-2015-17944
• 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: Health Professional
• Type of Report: Initial
• Report Date: 12/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.415
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 8 UNKNOWN LOCKING SCREWS
• Patient Outcome(s): Required Intervention
• Patient Weight: 89