MAUDE Adverse Event Report: SMITH AND NEPHEW LEFT BIRMINGHAM RESURFACING HIP

Model Number 74122160

Device Problems Metal Shedding Debris (1804); Noise, Audible (3273)

Patient Problems Fatigue (1849); Unspecified Infection (1930); Pain (1994); Rash (2033); Toxicity (2333); Disability (2371)

Event Date 04/26/2011

Event Type  Injury  

Event Description

My birmingham hip resurfacing system flaked metal into my bloodstream almost immediately, i have metallosis, and have had serious health problems including mental fog, extreme fatigue and horrible rash.After 2.5 years, my doctor did a revision.He said it was bad and needed to come out.During the revision, i got nontuberculous mycobacteria.Had to have another surgery in 3 weeks to get that out.I am having my hip aspirated next week to make sure all the infection was cut out.Metal levels have gone down, but still can't drive a car or do much.The hip made noises almost immediately when it was put in, and i had severe groin pain.I went to 17 doctors in a year and a half to tray to find out what was wrong.Ortho doctor finally did another metal test, and saw that the levels were elevated and did the revision.

• Brand Name: LEFT BIRMINGHAM RESURFACING HIP
• Type of Device: LEFT BIRMINGHAM RESURFACING HIP
• Manufacturer (Section D): SMITH AND NEPHEW
• MDR Report Key: 3573319
• MDR Text Key: 4076643
• Report Number: MW5033833
• Device Sequence Number: 1
• Product Code: NXT
• 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: 01/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 74122160
• Device Lot Number: 08HW18643
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 86