MAUDE Adverse Event Report: SMITH AND NEPHEW, INC BIRMINGHAM HIP RESURFACING(BHR) ; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL ON METAL, RESURFACING

Device Problem Noise, Audible (3273)

Patient Problem Toxicity (2333)

Event Date 11/13/2018

Event Type  Injury  

Event Description

I had hip resurfacing procedure on right hip on (b)(6) 2017.Yearly follow up scheduled on (b)(6) 2018, after squeaking coming from the resurfaced hip.Blood tests reveal chromium blood level of 10 and cobalt level of 8.5.

• Brand Name: BIRMINGHAM HIP RESURFACING(BHR)
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL ON METAL, RESURFACING
• Manufacturer (Section D): SMITH AND NEPHEW, INC
• MDR Report Key: 8297039
• MDR Text Key: 135612652
• Report Number: MW5083623
• 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: 01/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/31/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Weight: 84