MAUDE Adverse Event Report: SMITH AND NEPHEW METAL ON METAL HIP IMPLANT; PROSTHESIS, HIP

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Toxicity (2333)

Event Date 09/28/2009

Event Type  Injury  

Event Description

On (b)(6) 2009, i was implanted with a smith and nephew metal on metal total hip replacement in my left hip.Since 2013, and annually thereafter, my blood levels for cobalt and chromium have been monitored and the levels have escalated every year.Finally, in 2017 it was recommended to me that i remove this implant system and replace it with one that is not metal on metal.I did that (b)(6) 2018.

• Brand Name: METAL ON METAL HIP IMPLANT
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): SMITH AND NEPHEW
• MDR Report Key: 7590911
• MDR Text Key: 110777329
• Report Number: MW5077750
• Device Sequence Number: 1
• Product Code: JDG
• 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: 06/08/2018

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: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/11/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: OTC MEDS: NONE. ; RX MEDS: NEW NON-METAL ON METAL LEFT HIP IMPLANT.
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 49 YR