MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS, GMBH HIP RESURFACE LEFT TOTAL HIP RIGHT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL RESURFACING

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Emotional Changes (1831); Memory Loss/Impairment (1958); Pain (1994); Thyroid Problems (2102); Weakness (2145); Toxicity (2333); Depression (2361); Shaking/Tremors (2515); No Code Available (3191)

Event Date 10/01/2018

Event Type  Injury  

Event Description

I got a double smith & nephew hip implant, metal on metal in (b)(6) 2008.I have had nothing but trouble from the get go.Severe pain, weakness, loose hip, it has been awful.Also suffer from high cobalt blood levels 8.1 - up from 5.0 a few years back.I suffer from many problems associated with cobalt poisoning.Cloudy headedness, non lucid, forgetful, quick to anger, depression, tremors, cardiomyopathy, hypothyroidism.

• Brand Name: HIP RESURFACE LEFT TOTAL HIP RIGHT
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS, GMBH
• MDR Report Key: 7999540
• MDR Text Key: 124975076
• Report Number: MW5080769
• 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: 10/20/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention; Disability
• Patient Age: 54 YR
• Patient Weight: 122