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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Encephalopathy (1833); Fatigue (1849); Memory Loss/Impairment (1958); Toxicity (2333); Shaking/Tremors (2515)

Event Date 01/09/2020

Event Type  Injury  

Event Description

On (b)(6) 2009, he received a left total hip resurfacing arthroplasty for osteoarthritis.The implant used a smith & nephew birmingham resurfacing with a size 54 cup and a size 48 head.On (b)(6) 2018, his whole blood cobalt level was 5.1 mcg/l and serum / plasma chromium level was 5.7 mcg/l.He complained of rest tremor in the right hand, fatigue, some memory problems, and some balance issues.His fdg pet brain scan with neuro q analysis notable for focal and generalized hypometabolism consistent with chronic toxic encephalopathy.Confounding factor was presence of zimmer metal on metal durom tha on the right side.This was revised on (b)(6) 2018.Fluid was aspirated from the right hip during revision, cobalt level of the right hip fluid was 440 mcg/l.And chromium level of right hip fluid was 190 mcg/l.Following revision of the right hip, the only potential source of cobalt remaining in his body was the retained left bhr, and on (b)(6) 2019, his blood cobalt was 3.2 mcg/l, and the urine cobalt was 17.6 mcg/l.On (b)(6) 2019 blood cobalt was 1.5 mcg/l and urine cobalt was 13.6 mcg/l.A metal suppression mri of the left birmingham hip, from (b)(6) 2018 showed, at that time, an intracapsular cystic pseudotumor, which was about 6 cm in diameter.Repeat metal suppression mri of the left hip from september of 2019 showed again the cystic pseudotumor with progress of muscle edema / atrophy of the left iliacus muscle.His cobalt levels remain persistently elevated suggested possible wear of his bhr.On (b)(6) 2020, his whole blood cobalt level was 1.4 mcg/l, and his urine cobalt level was 14.6 mcg/l.He is taking a supplemental dose of 600mg of n-acetylcysteine per day for cobalt chelation.Since the revision of his right durom metal on metal hip, he believes that his balance issues have resolved.He also believes his memory has improved.He still has a visible rest tremor although it is not as bad as it was; 3425_mom_bhr.Fda safety report id# (b)(4).

• Brand Name: SMITH & NEPHEW BIRMINGHAM HIP RESURFACING
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED/ METAL/METEL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD.
• MDR Report Key: 9616118
• MDR Text Key: 176097403
• Report Number: MW5092374
• 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: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2020
• 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: 189 YR
• Patient Weight: 86