MAUDE Adverse Event Report: SYNTHES USA; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE

Device Problem Fitting Problem (2183)

Patient Problem Wound Dehiscence (1154)

Event Type  Injury  

Event Description

It was reported that a left femoral variable angle condylar plate and screws were implanted approximately three (3) weeks ago during an open reduction internal fixation (orif) procedure of a left, periprosthetic distal femur fracture.On an unknown date thereafter, the patient experienced left lateral hip wound dehiscence.The patient required a second surgery as a result of the wound dehiscence and the discovery of two (2) screws backing out of the plate.During the revision, it was determined that all the distal locking screws were loose.The plate remained implanted, but five (5) new screws were utilized.The procedure was successfully completed with no surgical delay reported.This report is for one (1) unknown condylar plate.This report is 6 of 6 for (b)(4).

Manufacturer Narrative

Additional patient information: patient height is reported as 5 feet 9 inches.Patient weight is reported as being between 220lbs.And 240lbs.This report is for one (1) unknown condylar plate.The condylar plate was not explanted during the revision procedure on july 23, 2015.The device remains in the patient.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.

• 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: 4952542
• MDR Text Key: 6639693
• Report Number: 2520274-2015-15073
• Device Sequence Number: 1
• Product Code: JDP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/23/2015
• 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
• Patient Age: 67 YR