MAUDE Adverse Event Report: STRYKER ORTHOPEDICS STRYKER ORTHOPEDICS ACCOLADE HIP REPLACEMENT; SHELL

Model Number ACCOLADE

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Inadequate Pain Relief (2388); Ambulation Difficulties (2544); Test Result (2695)

Event Type  Injury  

Event Description

On (b)(6) 2010, i had a right total hip replacement surgery with stryker accolade model at (b)(6) hosp by dr.(b)(6), orthopedic surgeon.Summer 2012 - until now - chronic and severe right groin and right hip pain.On (b)(6) 2015, right total hip revision surgery.Right groin and right hip pain noted on (b)(6) 2011.Metal-ion blood test done with serum chromium high and serum cobalt within normal limits.Fall 2012, i went to dr.(b)(6), orthopedic surgeon who performed right total hip replacement - stryker brand, accolade model, on (b)(6) 2010 at (b)(6) hospital.He minimized my status of severe-chronic pain and said i needed to exercise more.Pain continued, i saw dr.(b)(6) at (b)(6) and he suggested an mri of the hip of caudal block injections but never followed through within normal limit.I have not hired an attorney as of this date (b)(6) 2015, i am concerned the doctor will not give me the exchanged stryker accolade parts removed (b)(6) 2015, the doctor has an on-going relationship with stryker.I have been spending most days and nights in bed due to such severe pain for 1.5 years.Right hip: degeneration.

• Brand Name: STRYKER ORTHOPEDICS ACCOLADE HIP REPLACEMENT
• Type of Device: SHELL
• Manufacturer (Section D): STRYKER ORTHOPEDICS
• MDR Report Key: 5018265
• MDR Text Key: 24926390
• Report Number: MW5055543
• Device Sequence Number: 3
• Product Code: MEH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Report Date: 08/07/2015
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/01/2015
• Device Model Number: ACCOLADE
• Device Catalogue Number: 502-03-50D
• Device Lot Number: MJEX61
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 81