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

Device Problems Material Fragmentation (1261); Patient-Device Incompatibility (2682)

Patient Problems Purulent Discharge (1812); Hearing Impairment (1881); Failure of Implant (1924); Memory Loss/Impairment (1958); Pain (1994); Blurred Vision (2137); Irritability (2421); Sleep Dysfunction (2517); Ambulation Difficulties (2544); Cognitive Changes (2551)

Event Date 07/02/2018

Event Type  Injury  

Event Description

In (b)(6) 2013, she received a right tha for osteoarthritis of the right hip.This was a metal-on-metal birmingham hip resurfacing (bhr) by (b)(6) md, in (b)(6).In 2016, she started developing progressive right lateral hip pain with activity and at rest.She also had ongoing issues with degenerative disc disease and has previously experienced what she described as sciatic pain.Around the same time, she also noticed a sudden increase in balance issues, changes in her memory, and word-finding issues.She describes that she has felt like she in a constant haze.She also noticed irritability.Her mood kept her from wanting to do activities but her energy level is stable.She was newly diagnosed with sleep apnea.She became hard of hearing and noticed blurred vision despite refractive modifications and cataracts correction.On (b)(6) 2018, blood cobalt level was 4.1 ppb and blood chromium level was 4.8 ppb.On (b)(6) 2018, her whole blood cobalt level of 3.8 ppb and a urine cobalt level of 3.3 ppb.Metal suppression mri of the right hip, done on (b)(6) 2018 showed a large fluid collection measuring 9 cm in maximal dimension which is around her right hip resurfacing, particularly posteriorly.Most of the fluid is in the trochanteric area and you can see the fluid communicating with the joint via the posterior capsule.The anterior superior capsule seems okay.Her hip abductor tendons look okay, but the fluid is in close opposition to the hip abductor tendons, so she may be experiencing some early attrition of the tendons.Her fdg pet brain scan was notable for focal and generalized hypometabolism suggestive of chronic toxic encephalopathy due to cobalt exposure.On (b)(6) 2018, she had the right tha revised to a zimmer mlt size 10 eo stem, delta option ceramic ball size 36mm +0 neck, an x3 high wall polyethylene liner.There was a large purulent appearing effusion, which was collected and sent for cobalt and chromium level.The cobalt level of the right hip joint fluid was 850 ppb and the chromium level was 1,000 ppb.The anterior hip capsule was thickened but intact, and the posterior hip capsule was partially involved in armd but reconstructable.There was a large posterior cystic pseudotumor that was resected.The acetabular component was well positioned and well ingrown and after removal there was medial contained cystic bone deficiency.Fda safety report id# (b)(4).

• Brand Name: SMITH & NEPHEW METAL-ON-METAL BIRMINGHAM HIP; RESURFACING (BHR)
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL / METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW, INC.
• MDR Report Key: 9437526
• MDR Text Key: 170212972
• Report Number: MW5091512
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• 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: 70 YR
• Patient Weight: 77