MAUDE Adverse Event Report: STRYKER CORMET; #65 HEAD

Device Problem Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Hypersensitivity/Allergic reaction (1907); Pain (1994); Tissue Damage (2104); Vertigo (2134); Tingling (2171); Toxicity (2333); Arthralgia (2355); Numbness (2415); Lethargy (2560); Osteopenia/ Osteoporosis (2651)

Event Date 10/20/2015

Event Type  Injury  

Event Description

Stryker cormet (metal-on-metal) hip resurfacing system implanted in (b)(6) 2008 by (b)(6) installed a 6x56 mm cormet acetabular shell and a cormet # 65 head at (b)(6).Bulge on my upper left hip around implant incision developed and grew.It was warm to touch, activity decrease, moderate to severe pain, tingling in lower left leg and both feet feel numb.Mri shows fluid around implant and in the area of the bulge.Surgeon consultation suspects adverse reaction to the device and possible metal ion toxicity.Recommendation, remove implant as soon as possible and replace.Tissue damage around the implant site and bone loss is expected to complicate the revision surgery.I have been referred to a specialist surgeon for the procedure.If left untreated, the infection could be life-threatening, as i am also diabetic.In the last 12-18 months, i have experienced chronic lethargy, abdominal pain, vertigo, as well as muscle and joint pain throughout my body.

• Brand Name: CORMET
• Type of Device: #65 HEAD
• Manufacturer (Section D): STRYKER
• MDR Report Key: 5210436
• MDR Text Key: 30854587
• Report Number: MW5057740
• Device Sequence Number: 2
• Product Code: NXT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/04/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/04/2015
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention; Disability
• Patient Age: 59 YR
• Patient Weight: 110