MAUDE Adverse Event Report: ZIMMER GMBH ZIMMER DUROM METAL ON METAL HIP DEVICE; PROSTHESIS, HIP, FEMORAL, RESURFACING

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

Patient Problems Edema (1820); Encephalopathy (1833); Fatigue (1849); High Blood Pressure/ Hypertension (1908); Memory Loss/Impairment (1958); Neurological Deficit/Dysfunction (1982); Neuropathy (1983); Swelling (2091); Blurred Vision (2137); Toxicity (2333); Numbness (2415); Irritability (2421); Ambulation Difficulties (2544)

Event Date 02/12/2016

Event Type  Injury  

Event Description

¿(b)(6).¿ on (b)(6) 2007, patient received a left total hip arthroplasty for osteoarthritis of the left hip.The implant used was a zimmer durom acetabular shell size 52 with a size 7.5 extended offset neck, m/l taper stem, and 46-mm cobalt durom femoral head with a -4 neck length.In the summer of 2013, patient began noticing symptoms of parkinsonism.His hand froze while mousing, he progressively developed impediments in gait, and facial masking suggestive of parkinsonism.He also developed high blood pressure during this time.Beginning in (b)(6) 2016, he experienced profound fatigue and memory changes that caused him to start taking notes to remember things and word-finding issues.His mood was also affected as he began noticing that he was becoming more irritable.He also noted that his right eye had been getting blurrier on the right side in far sight peripheral neuropathy of the bilateral lower extremities.Relatively new onset of edema in bilateral lower extremities.On (b)(6) 2016, his whole blood chromium level was 0.6 mcg/l and whole blood cobalt level was 11.7 mcg/l.On (b)(6) 2017, his cobalt urine level was 1.2 mcg/l, cobalt serum/plasma level was 0.5 mcg/l, and whole blood cobalt level 0.5mcg/l.Metal suppression mri of the left hip showed a probable pseudotumor at the posterior medial aspect of the left joint.On (b)(6) 2017, he underwent an fdg pet brain imaging study, which showed significant clusters of brain hypometabolism in the temporal lobe areas consistent with chronic toxic encephalopathy.There were also some hypermetabolic areas of the basal ganglia, which was thought to be related to the medications he was taking for parkinson¿s disease.On (b)(6) 2017, he had the left hip revised for ¿metallosis¿ and concern that his cobalts were contributing to his parkinsonism.Revision implant was a biomet g7 three hole acetabular shell size 56 with three acetabular component, his cobalt levels will be continuously monitored.On (b)(6) 2018, his cobalt urine level and whole blood cobalt level were both 0.3 mcg/l.On (b)(6) 2019, his urine cobalt level was 0.2 mcg/l and his blood cobalt level was 0.4 mcg/l.Since revision of his left hip, he has noticed that his muscles are looser.He feels his gait has improved and has noticed that he can move faster.His parkinson¿s medications have not changed since his diagnosis in 2013.He takes sinemet and isradipine.He has noticed improvement in his memory and word-finding issues.He no longer keeps notes to remember things.He has been sleeping better and has been less irritable.He was diagnosed with sleep apnea last summer and has been using a cpap machine.He has also noticed improvement in his energy level.He still has numbness in his hands and feet, but feels this is getting better.

• Brand Name: ZIMMER DUROM METAL ON METAL HIP DEVICE
• Type of Device: PROSTHESIS, HIP, FEMORAL, RESURFACING
• Manufacturer (Section D): ZIMMER GMBH
• MDR Report Key: 9622010
• MDR Text Key: 176375050
• Report Number: MW5092428
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 01/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2020
• 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; Required Intervention
• Patient Age: 50 YR
• Patient Weight: 107