MAUDE Adverse Event Report: SMITH AND NEPHEW ORTHOPAEDICS LTD. SMITH AND NEPHEW BIRMINGHAM HYBRID HIP RESURFACING; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/ METAL RESURFACING

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Atrial Fibrillation (1729); Emotional Changes (1831); Headache (1880); Hearing Impairment (1881); Hypersensitivity/Allergic reaction (1907); Memory Loss/Impairment (1958); Pain (1994); Tinnitus (2103); Blurred Vision (2137); Toxicity (2333); Sleep Dysfunction (2517); Confusion/ Disorientation (2553)

Event Date 08/07/2017

Event Type  Injury  

Event Description

On (b)(6) 2007, she received a right hip resurfacing tha with a smith and nephew birmingham hybrid hip resurfacing.It was revised for abnormal dislocation on (b)(6) 2007.In 2017, she began experiencing progressive symptoms of slight subluxation and posterior, lateral, and anterior right hip pain.On (b)(6) 2017, her blood cobalt level was 2.8 ppb and urine cobalt level was 8.4 ppb.In addition to new symptoms at the right hip, she began experiencing constant headaches beginning in (b)(6) 2016, difficulty hearing in restaurants or certain pitches of voices and ringing in the ears hat has been ongoing since 2014, blurred vision despite refractive modifications, difficulty with focusing at work and memory problems, atrial fibrillation, episode of confusion/disorientation, new diagnosis of sleep apnea and new mood disorder.He fdg pet brain scan was notable for focal and generalized hypometabolism consistent with chronic toxic encephalopathy due to cobalt exposure.A metal suppression mri of the right hip showed signs of mild adverse reaction to metallic debris.Her right tha was revised on (b)(6) 2017 to a stryker exeter size 44 #0 cemented stem, continuum 56 od shell fixed with 4 dome screws, vivacity-e 36mm id liner, ceramic delta option head size 36mm+2.5 neck.The hip abductor tendons were intact, anterior hip capsule was thickened consistent with adverse reaction to metallic debris, the moderate synovium was tinged orange-brown consistent with mild metallosis.The posterior hip capsule was thin and the external rotators were not present.The acetabular component was well fixed (cemented and ingrown) and was a bit sleep and overly anteverted.After removal there was focal posterior constrained bone deficiency treated with bone grafting from the acetabular osteophytes reamings.Cobalt level of the right hip fluid was 120 ppb.Fda safety report id # (b)(4).

• Brand Name: SMITH AND NEPHEW BIRMINGHAM HYBRID HIP RESURFACING
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/ METAL RESURFACING
• Manufacturer (Section D): SMITH AND NEPHEW ORTHOPAEDICS LTD.
• MDR Report Key: 9410823
• MDR Text Key: 169514060
• Report Number: MW5091416
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 68