MAUDE Adverse Event Report: CORIN CORMET HIP RESURFACING SYSTEM SIZE 7/50MM

Device Problems Break (1069); Loose or Intermittent Connection (1371); Malposition of Device (2616); Device Dislodged or Dislocated (2923)

Patient Problems Inflammation (1932); Pain (1994); Toxicity (2333); Joint Dislocation (2374); Collapse (2416)

Event Date 04/11/2017

Event Type  Injury  

Event Description

I had a left hip resurfacing performed in (b)(6) of 2009.Corin's cormet hip resurfacing device was implanted.After several months of pain in my left hip.I made an appointment with my orthopedic surgeon on (b)(6) 2012.He referred me for a bone scan on (b)(6) 2012 to rule out microfractures because the x-ray did not show anything unusual.I returned for the results on (b)(6) 2012 and was told that the bone scan was negative.Dr (b)(6) then ordered a blood test for cobalt and chromium.The blood work showed elevated levels of both metals and i was advised to repeat this test every 6 months.Over time these levels slowly increased.By (b)(6) of 2016, the pain in my left hip had increased to the point that on (b)(6) 2016 i made an appointment with dr (b)(6) for (b)(6) 2017.After viewing my x-ray, dr (b)(6) recommended that i have a total revision.I was experiencing an unusual issue with mandibular tori, so dr (b)(6) referred me to an oral surgeon to resolve this issue before the revision due to serious risk of complications with the implant.After 2 surgeries to resolve the tori issue, my wife (b)(6) and i began preparing for the painful process of recovery, as she would be my caretaker once again.On the evening of (b)(6) 2017, while attending our granddaughter's softball game, my hip suddenly became more painful than normal.I told my wife that i was going to sit in the truck.As i walked to the truck, i felt a "thudding" sensation from my heel all the way up to the hip.Shortly after we returned home, my left hip suddenly became unbearably painful and i collapsed on the floor.Unable to pick me up, (b)(6) brought my walker down from the attic.I went to bed hoping that the pain would subside.The pain did not let up any during a very long, agonizing and sleepless night.By 3:30am, i knew i had to get up and take something for the excruciating pain.After 90 minutes of struggling, i finally got both feet on the floor and got dressed and awakened (b)(6) and asked her to take me to the er.On the morning of (b)(6) 2017, the er dr took an x-ray of my hip.Of course the x-ray did not reveal the problem with the implant.He prescribed a steroid round, muscle relaxer, and pain meds and got me an appointment with dr.(b)(6) for (b)(6) 2017.Upon comparing the x-ray he had done in (b)(6) with the one taken at the er he could see that the implant had shifted to a different location.As dr.(b)(6) examined me, he said that my femur was grossly loose and scheduled me for a revision on (b)(6) 2017.The surgery revealed that the stem of the cormet device had broken and my hip was basically dislocated.I obtained a copy of the pathology report which describes chronic inflammation at the site of the device, and also includes the serial numbers for the components.

• Brand Name: CORMET HIP RESURFACING SYSTEM SIZE 7/50MM
• Type of Device: CORMET HIP RESURFACING SYSTEM SIZE 7/50MM
• Manufacturer (Section D): CORIN
• MDR Report Key: 6785106
• MDR Text Key: 82501417
• Report Number: MW5071481
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• 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: 08/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Weight: 95