MAUDE Adverse Event Report: SYNTHES USA 4.5MM VA-LCP CURVED CONDYLAR PLATE/10HOLE/230MM/RT-STER; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE

Catalog Number 02.124.410S

Device Problems Fitting Problem (2183); Component or Accessory Incompatibility (2897)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that a distal femoral fracture became displaced when three (3) variable angle locking screws backed out of a variable angle condylar plate.The initial distal femoral stem prostheses procedure for a peri-prosthetic distal femur fracture took place on (b)(6) 2015.It was reported that the patient, who was described as ¿very obese,¿ mobilized early postoperative.An x-ray taken on (b)(6) 2015 confirmed the displaced fracture and showed the backed-out screws.A revision procedure to the knee stem occurred on (b)(6) 2015.This report is 3 of 3 for (b)(4).

Manufacturer Narrative

Patient¿s date of birth and weight are unknown.Event date: unknown.Additional product codes for this report include hrs and hwc.(b)(6).Investigation could not be completed and no conclusion could be drawn as no device was returned.Without a lot number, the device history record review could not be requested.Device 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.

Manufacturer Narrative

Device 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/10HOLE/230MM/RT-STER
• Type of Device: IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES USA
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4590499
• MDR Text Key: 5339724
• Report Number: 2520274-2015-11694
• Device Sequence Number: 1
• Product Code: JDP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PK110354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.410S
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2015
• 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
• Patient Outcome(s): Required Intervention