MAUDE Adverse Event Report: SYNTHES USA 4.5MM LCP PROXIMAL TIBIA PLATE4 HOLES/82MM-LEFT; PLATE, FIXATION, BONE

Catalog Number 240.037

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Pain (1994); Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

This device was used for treatment, not diagnosis.Patient initials (b)(6).Date of event: unknown.(b)(4).Date of implant: (b)(6) 2008.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.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 the patient had a lateral tibial plateau fracture surgery on (b)(6) 2008 using synthes plates, screws and dbx putty.The procedure was completed successfully but after the surgery; the patient had difficulty walking due to a swollen leg and experienced ongoing issues of serve pain in her leg.Also after the surgery the patient had a post fall that injured her left knee and right wrist resulting in a right distal radius fracture and left lateral plateau fracture.On (b)(6) 2008, the patient had another surgery; an open reduction internal fixation procedure was performed on the left knee using two (2) plates (4 hole condylar plate, 6 hole plate) and nine (9) screws (two (2) 4.5 mm bicortical screws, two (2) 6.5 mm cancellous screws which one (1) was placed in the most proximal screw site, five (5) 5.0 mm locking screws - two (2) placed in proximal condylar plate; one (1) obliquely across the fracture; one (1) in most distal screw hole and one (1) 5.0 mm conical screw) and dbx putty (4 ml) and short arm cast was applied to the right forearm.Post-surgery the patient did not have any issues with her right wrist.It was reported that the procedure was completed successfully and the patient is stable.This report is 1 of 10 for (b)(4).

Manufacturer Narrative

Device has reported not been explanted.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 additionally reported the patient continues to experience ongoing pain, suffering, stress, many emergency room visits.The patient feels the hardware locks up which cause the patient to fall, loose balance and the patient¿s leg stays swollen all the time around the knee.The patient¿s doctor has noted that the patient has fluid buildup on and around the implanted hardware.

• Brand Name: 4.5MM LCP PROXIMAL TIBIA PLATE4 HOLES/82MM-LEFT
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5844563
• MDR Text Key: 51110154
• Report Number: 2520274-2016-13861
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052390
• 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: 07/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 240.037
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/23/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention