MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS, INC. MICROPORT (FORMERLY(WRIGHT MEDICAL TECHNOLOGY)ROFEMUR COBALT CHROME MODULAR NECK; PROSTHESIS,HIP,SEMI-CONSTRAINED,METAL/CERAMIC/POLYMER,CEMENTED OR NON-POROUS,UNC

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Fatigue (1849); Inflammation (1932); Pain (1994); Complaint, Ill-Defined (2331); Toxicity (2333); Depression (2361); Reaction (2414); Irritability (2421); Shaking/Tremors (2515); Test Result (2695); No Code Available (3191)

Event Date 01/31/2019

Event Type  Injury  

Event Description

A pt, (b)(6); on (b)(6) 2013, the pt received simultaneous bilateral total hip arthroplasties.This report is for an adverse event relating to the right hip, and a separate report will be filed for the left hip.The right hip implant was a wright medical technology profemur renaissance size 15 standard flare stem, a 56mm dynasty porous-coated shell, a 6.5 x 50mm cancellous bone screw, 36mm +0 alumina ceramic femoral head, a short vv cobalt-chrome modular neck, and a 36mm a class polyliner.After the hip replacements, the pt initially did great and had no symptoms and resumed regular activity.The pt resumed hiking, walking, cycling, and playing hockey.The pt began suddenly experiencing bilateral anterolateral hip and groin pain of the right greater than left hip, which became progressive.Metal-suppression mri studies of the hips showed evidence of adverse reaction to metallic debris with pseudotumors at both hips.This adverse reaction was much worse at the right hip than the left.The pt also began experiencing symptoms of increased rest tremor of both hands, increased irritability and depressed mood, diminished pain tolerance and general resilience, and excessive fatigue.On (b)(6) 2018, the pt's urine cobalt level was 21.1 mcg/l and blood cobalt level was 4.1 mcg/l.On (b)(6) 2018, he had an fdg pet brain scan.This study was analyzed by neuroq software.According to this analysis, the aggregate score of all the hypometabolic regions of the brain was -119, involving 55 regions and 13 abnormal cluster regions.One of the abnormal cluster regions is the right inferior posterior temporal lateral cortex with a score of -1.99.On (b)(6) 2018, an mri of the brain stem without contrast was obtained and analyzed with neuroquant software.The volumetric evaluation showed that there was a significant decrease in cerebral white matter, measuring in the 2nd percentile on the left and in the 4th percentile on the right.There also was volume loss at the cingulate isthmus, paracentral gyrus, the putamen, and the globus pallidum.On (b)(6) 2018, pt had an echocardiogram, which indicated normal size and wall thickness of the left ventricle with normal diastolic function.Given the pt's progressive symptoms, mri findings, elevated cobalt levels, and concern of cobalt toxicity, on (b)(6) 2019, the pt's right hip was revised.The cobalt-chrome modular neck was revised to a microport (formerly) wright medical technology) tiaiv vv 8 modular neck, new delta ceramic head size 36mm +3.5 and an a-class high-wall socket liner.The trunnion and head bore shoed notable corrosion debris and the neck-stem taper showed severe corrosion debris.There was no significant lysis about the acetabular and femoral components.The posterior capsule was thickened and friable, anterior capsule was severely thickened and friable, abduction tendons were inflamed but intact.Stability profile of old hip after posterior capsulotomy showed posterior dislocation at 45 degrees ir in 90 flexion due to anterior impingement from the pseudotumor.Frozen section of right hip capsule notable for extensive necrosis with perivascular lymphocytic infiltrates, compatible with aseptic lymphocytic vasculitis - associated lesion (alvl).Fluid from right hip joint believed to be diluted about 1:5 with local anesthetic was collected and the cobalt level of this diluted fluid was 230mcg/l.On (b)(6) 2019, pt blood cobalt level post-revision of the left hip was 1.9 mcg/l and urine cobalt level was 9.2 mcg/l.This suggests that the remaining left tha is also contributing to his elevated cobalt level.The left hip implant was a wright medical technology profemur renaissance size 14 reduced flare stem, a 56mm dynasty porous-coated shell, 36mm +0 alumina ceramic femoral head, a short arvv2 cobalt-chrome modular neck, and a 36mm a class polyliner.Fda safety report id# (b)(4).

• Brand Name: MICROPORT (FORMERLY(WRIGHT MEDICAL TECHNOLOGY)ROFEMUR COBALT CHROME MODULAR NECK
• Type of Device: PROSTHESIS,HIP,SEMI-CONSTRAINED,METAL/CERAMIC/POLYMER,CEMENTED OR NON-POROUS,UNC
• Manufacturer (Section D): MICROPORT ORTHOPEDICS, INC.
• MDR Report Key: 9559393
• MDR Text Key: 174270245
• Report Number: MW5092080
• Device Sequence Number: 1
• Product Code: LZO
• 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: 01/03/2020

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: 01/06/2020
• 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: 65 YR
• Patient Weight: 92