MAUDE Adverse Event Report: SMITH AND NEPHEW SYNERGY FEMORAL COMPONENT

Lot Number 07BM09546

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dyspnea (1816); Fatigue (1849); Itching Sensation (1943); Rash (2033); Excessive Tear Production (2235); Blood Loss (2597)

Event Date 04/10/2007

Event Type  Injury  

Event Description

Reporter stated that her mom had a left hip replacement on (b)(6) 2007.She had three blood transfusions due to a big blood loss during the surgery.A year later symptoms started gradually with red rashes on her skin, her face, inner thigh, neck, back, trunk, and near the incision site.The rash usually starts as a circle or lines and progresses all over and becomes very itchy.Client saw the first dermatologist in 2008, then another in 2009, and in 2015 saw an allergist.Mainly warm weather and/or warm baths aggravate the rash but symptoms still manifest even in cold weather.Topical creams have been administered but these creams only help to lighten the skin temporarily.Other symptoms client has experienced include, fatigue, shortness of breath and client has to "pull" her leg out of the car seat as she tries to get out of the car.In 2011 client's eyes started tearing excessively and she saw an ophthalmologist as well.Client currently experiencing these symptoms.

• Brand Name: SYNERGY FEMORAL COMPONENT
• Type of Device: FEMORAL COMPONENT
• Manufacturer (Section D): SMITH AND NEPHEW
• MDR Report Key: 5029074
• MDR Text Key: 24099656
• Report Number: MW5055699
• Device Sequence Number: 4
• Product Code: JDG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Report Date: 08/19/2015
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 04/02/2017
• Device Lot Number: 07BM09546
• Is the Reporter a Health Professional?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22 YR
• Patient Weight: 64