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

Device Problem Device Slipped (1584)

Patient Problems Headache (1880); Memory Loss/Impairment (1958); Pain (1994); Toxicity (2333); Reaction (2414); Irritability (2421)

Event Date 12/18/2019

Event Type  Injury  

Event Description

Pt id: (b)(6); on (b)(6) 2009, she received a right total hp arthroplasty for osteoarthritis and hip dysplasia.The implant was a smith & nephew birmingham resurfacing with a size 50mm od up, 42mm birmingham resurfacing femoral head component, 1 package of simplex p cement with 1.2g tobramycin.The right tha worked well until about (b)(6) of 2019, when she began experiencing progressive groin and lateral hip pain when she works out on a treadmill.A metal suppression mri of the right hip was obtained on (b)(6) 2019 showed a definite adverse reaction to metal debris with increased fluid at the hip and insufficiency of the posterior hip capsule with the fluid pooling posteriorly.Hip abductor tendons may have early involvement as well.Plain x-rays of the hip and pelvis show a well-positioned birmingham hip resurfacing with a little bit of focal lysis at the ingrowth acetabular bone interface and a little bit of bone absorption around the superior femoral neck.On (b)(6) 2019, her urine cobalt level was 38.2 mcg/l and her whole blood cobalt level was 15.7 mcg/l.On (b)(6) 2019, while stepping out of her car, she slipped on the icy running boards of her truck, and landed on her left shoulder and her left temple.Ct scan made of the head on the same day of the fall showed no evidence of intracranial process.She did not lose consciousness but felt "funny".Ever since then she has had an intermittent headache that is holocephalic but worse in focal areas.She notices when she is stressed out or is trying to focus and it feels like vice-grip tightening.She also developed severe phonophobia, with certain sounds aggravating her headache.She has also developed poor memory, irritability, and trouble concentrating.No photophobia and no nausea.She has tried botox injections of the neck and head, which were not helpful.She underwent an fdg pet brain scan due to concern of possible ongoing symptoms due to cobalt toxicity.Fda safety report id# (b)(4).

• Brand Name: SMITH & NEPHEW BIRMINGHAM HIP RESURFACING
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD.
• MDR Report Key: 9636678
• MDR Text Key: 177029416
• Report Number: MW5092544
• 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: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2020
• 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
• Patient Age: 58 YR
• Patient Weight: 58