MAUDE Adverse Event Report: SMITH & NEPHEW SMITH 7 NEPHEW BIRMINGHAM HIP RESURFACING; PROSTHESIS HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Inflammation (1932); Memory Loss/Impairment (1958); Necrosis (1971); Irritability (2421); Shaking/Tremors (2515); No Code Available (3191)

Event Date 05/23/2019

Event Type  Injury  

Event Description

On (b)(6) 2011, ms received a right tha for osteoarthritis.The implant was a metal-on-metal smith & nephew birmingham hip resurfacing with a size 50 head and a size 56 shell.In (b)(6) of 2018, he presented with right hip soreness aggravated by sleep hurting the previous fall.He concomittantly noted progressive forgetfulness, irritability, high-frequency hearing loss, and tremor over 4 years.His family history was notable for alzheimer's disease.Examination was notable for groin soreness on straight leg raise against resistance, no limp, and a fine rest tremor of all fingers most notable with hands supinated and fingers actively partially spread.Radiographs showed well-positioned bhr components without evidence of loosening, bone lysis, or wear.Following cobalt levels were observed during this time; (b)(6) 2018: cobalt, urine was 2.0 mcg/l, and cobalt, blood was 1.1 mcg/l; (b)(6) 2018 cobalt, urine was 1.3 mcg/l and cobalt, blood was 0.7 mcg/l, (b)(6) 2018: cobalt, urine was 0.7 mcg/l, and cobalt, blood was 1.1 mcg/l.On (b)(6) 2018, cobalt, urine was 3.1 mcg/l and cobalt, blood was 1.6 mcg/l.Given his elevated cobalt level, he was treated with 600mg of n-acetylcysteine 3 times per day and this did lower his levels, but they remained elevated above the threshold for concern.He also noted progression of his cognitive symptoms.Metal suppression mri was notable for hip capsule thickening and periprosthetic lymphadenopathy consistent with an armd.Fdg pet brain scan analysis indicated significant hypometabolism.The most affected cluster areas were the right inferior-lateral-posterior-temporal-cortex and left broca's-region.Given these findings, pt elected to have the hip revised on (b)(6) 2019.The resurfacing was revised to a smith & nephew multi hole 58 r3 socket supplemented by four screws, definitive liner used is 36 id with crosslinked polyethylene, a synergy size 15 high offset uncemented definitive stem and a 36mm +0 oxonium head.He had a moderate cystic pseudotumor most notable as soon as a cut was made to the tensor fascia femoris, which was quite thin and attenuated.There was a serous sort of cavity directly beneath the tensor fascia femoris.Posterior capsule was thickened and short external rotators were intact but attenuated.There was moderate inflammation of the synovium with synovial hypertrophy.There was moderate hip effusion.Pathology report of frozen hip tissue section notable for presence of sings of chronic inflammation.Histiocytes / macrophages, evidence of metal particles and dusty black histiocytes, few multinucleated giant cells, focal surface necrosis, and synovial hyperplasia.Sample of hip fluid was diluted 1:10 with anesthetic and the cobalt level of this diluted fluid was 14 mcg/l.Post-revision, on (b)(6) 2019, cobalt, urine was 0.3 mcg/l and cobalt, blood was 0.4 mcg/l.Fda safety report id# (b)(4).

• Brand Name: SMITH 7 NEPHEW BIRMINGHAM HIP RESURFACING
• Type of Device: PROSTHESIS HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW; london ; UK
• MDR Report Key: 9505588
• MDR Text Key: 172440456
• Report Number: MW5091805
• 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: Physician
• Type of Report: Initial
• Report Date: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• 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?: Yes
• 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: 82