MAUDE Adverse Event Report: JOHNSON & JOHNSON THE TITANIUM INTRAMEDULLARY NAIL SYSTEM

Model Number 456.762SPFNA

Device Problem Insufficient Information (3190)

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994); Reaction (2414); Choking (2464); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671)

Event Date 12/02/2014

Event Type  Injury  

Event Description

On (b)(6) 2016 respect johnson and johnson, my name is (b)(6), a retired teacher living in (b)(6).I am writing this letter to tell you my personal experience of adverse reaction of a medical device.Because of a traffic accident, i had comminuted fracture of femur.On (b)(6) 2013, i had a surgery at (b)(6) hospital and implanted the titanium intramedullary nail system, medical equipment produced by johnson and johnson, imported by "(b)(4)." the effect of the operation was good at the first few months after the operation.However, 20 months after, the adverse reactions began to appear.For me, it has been all sorts of allergic symptoms: regular consumption of food became intolerable, eating boiled egg caused throat choking convulsion, a small amount of custard caused big and scary blister.I have to avoid eating soy beans, wheat flour, eggs and seafood, fish and shrimp.This in turn causes imbalance of nutrition.The daily medicine which had been taken regularly before has morphed into an allergens.I had the cause of this phenomenon examined and determined by (b)(6) hospital to be titanium metal allergy.My injured limb is aching all the time.I cannot move properly and have to rely on crutch to walk.The continuous pain in my left leg makes me suffer.I really feel helpless.To the appropriate crowd suffering from fracture accident, the implanted medical devices is to heal the wounded and rescue the dying and helpful, but for people not suitable for the implant, the adverse reaction is suffer.The adverse reaction seriously damage people's health, and the chronic reaction involved and slim possibility of recovery make people nervous.As companies specialized in medical equipment production and trading, johnson and johnson, (b)(4) has the obligation to check whether the purchasers and users of their medical equipment, that is the relevant (b)(6) hospitals, have the ability to screen those who are not suitable for medical equipment implant, and provide technical support, provide test items for blood serum level of heavy metal poisoning and standard value, and in the after-sale service in hospital marketing in (b)(6), take measures to deal with the adverse reactions.Please treat highly allergic patients who have been implanted with intramedullary nail system.Please also pay attention to collection of data regarding surgery serious adverse reaction several years after the surgery and regarding patient feedback.Sincerely yours.

• Brand Name: THE TITANIUM INTRAMEDULLARY NAIL SYSTEM
• Type of Device: INTRAMEDULLARY NAIL
• Manufacturer (Section D): JOHNSON & JOHNSON
• MDR Report Key: 5702729
• MDR Text Key: 46805226
• Report Number: MW5062681
• Device Sequence Number: 2
• Product Code: HSB
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/02/2016
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 456.762SPFNA
• Device Catalogue Number: 8049702
• Device Lot Number: 0107611819837188
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 73 YR
• Patient Weight: 65