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

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

Patient Problems Dyspnea (1816); Fatigue (1849); Memory Loss/Impairment (1958); Nausea (1970); Pain (1994); Dizziness (2194); Anxiety (2328); Toxicity (2333); Depression (2361); Shaking/Tremors (2515); Confusion/ Disorientation (2553); Test Result (2695)

Event Date 09/26/2018

Event Type  Injury  

Event Description

On (b)(6) 2018, dm received a right metal-on-metal smith and nephew birmingham hip resurfacing (bhr) by dr (b)(6) for osteoarthritis and increasing pain after a prior labral repair.Dm was recommended a bhr due to relatively high activity level.He was referred out of town to dr (b)(6) for this procedure.Prior to receiving the bhr, dm inquired about the possibility of developing metallosis, and according to dm, dr (b)(6) responded by stating that he had never had a pt with a case of metallosis.With this reassurance, dm proceeded with the procedure.Dm travelled back home and followed the directions for rehabilitation to the letter, including graduated increases in walking and the prescribed resistance exercises, and dm felt good progress.In (b)(6) 2018, dm experienced mild discoloration of urine.Urine culture was negative while the ua demonstrated no red blood cells.Urine appearance remains noticeable different to the pt.At 3 month post op evaluation, dm was cleared to ramp up all physical activity, dm began walking on a treadmill, when dm experienced the abrupt onset of considerable pain in the involved hip.In addition, dm suddenly felt systemically ill with nausea, excessive fatigue, tremors, dizziness, anxiety and disorientation.Thinking it was hypoglycemia, dm had something to eat, but his did not improve symptoms.Dm has not felt normal since this episode.Dm experienced sustained nervousness / anxiety, confusion, restlessness, tremulousness, an atypically rapid resting heart rate (90-100 bpm versus customary 50-60), orthopnea, and exercise intolerance.Dm was diagnosed with anxiety and depression related to stress and was prescribed paroxetine as well as prn medication for insomnia.These medications were ultimately unhelpful and was eventually diagnosed wit adjustment disorder by a counselor.Dm had three or four job interviews during this time that did not go well, as it was very difficult for dm to conceal symptoms of confusion and anxiety.Dm was changed to sertraline, which did reduce very troublesome anticholinergic symptoms, but without improvement in mood, mentation, energy or cardiac symptoms.On (b)(6) 2018, dm had a cobalt plasma level of 1.1 mcg/dl and a chromium plasma level of 1.2 mcg/l.Dm pursued intensive mental health care including genetic testing and on-site monitoring of response to possible changes in medication regimen.Dm was started on bupropion according to his testing results, but still continued to experience mental fog and forgetfulness.Neurocognitive testing suggested early fronto-temporal dementia (ftd) and brain mri demonstrated considerable fronto-temporal atrophy in anatomic areas.A neurologist suggested the possibility of a static encephalopathy resulting from a hypoxic-ischemic event following which functional re-writing potentiated by the profound known neonatal brain plasticity had restored function without replacing brain volume.An initial brain mri had been obtained in (b)(6) 2018 immediately prior to the surgery.This was obtained in view of the recent previous head trauma and transient concussive symptoms.On (b)(6) 2019, whole blood cobalt level was 0.6 mcg/l and cobalt urine was 2.2mcg/l.Fdg pet brain scan and analysis are in progress.Dm has also begun taking n-acetylcysteine at a supplemental dietary dose for cobalt chelation.Fda safety report id# (b)(4).

• Brand Name: SMITH & NEPHEW BIRMINGHAM HIP RESURFACING
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL
• Manufacturer (Section D): SMITH & NEPHEW ORTHOAEDICS LTD.
• MDR Report Key: 9506210
• MDR Text Key: 172564846
• Report Number: MW5091827
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2019
• 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: 61 YR