MAUDE Adverse Event Report: ZIMMER INC. ZIMMER DUROM METAL ON METAL HIP ; PROSTHESIS, HIP, FEMORAL, RESURFACING

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

Patient Problems Dyspnea (1816); Memory Loss/Impairment (1958); Pain (1994); Swelling (2091); Synovitis (2094); Anxiety (2328); Toxicity (2333); Depression (2361); Irritability (2421); Confusion/ Disorientation (2553)

Event Date 02/18/2016

Event Type  Injury  

Event Description

On (b)(6) 2007, (b)(6) received a right tha for end-stage osteoarthritis of the right hip.It was a zimmer durom metal on metal hip with a size 56 durom acetabular shell, 7.5 ml taper extended offset stem, and a 50mm+0 cobalt chrome head.In about 2013, he started developing progressive pain around the right hip especially with hip flexion and abduction.He noted no injuries at this time.He began doing formal pt for pain, but it did not improve.In (b)(6) 2015, he had a metal suppression mri made of the right hip which showed fluid in the joint that tracks to the trochanteric bursa and evidence of synovitis with a discrete pseudotumor in the lateral supra-acetabular area about 4cm in diameter as well as a partial tear of the medical aspect of the gluteus medius tendon attachment to the greater trochanter, all findings consistent with adverse reaction to metal debris.Blood and urine cobalt levels (collected on (b)(6) 2015) were also elevated at 1.6 ppb and 8.2 ppb respectively.He concomitantly noted cognitive decline, new onset of depression and anxiety, irritability, memory problems, disordered sleep, dyspnea on exertion, and mental fog.Echocardiogram on (b)(6) 2015, notable for grade 1 diabetic dysfunction consistent with cardiomyopathy common with cobaltism.Fdg pet brain scan showed focal and generalized hypometabolism consistent with chronic toxic encephalopathy.He elected to have the right hip revised on (b)(6) 2016 for increasing right hip pain, evidence of adverse reaction to metal debris on mri, elevated cobalt levels and concern of progressive chronic toxic encephalopathy due to cobalt exposure.The implant was revised to a zimmer 60mm od continuum multi-hole shell, vivacity-e liner 32mm id, and a 32mm +0 delta option ceramic head and 3 dome screws.The ml taper stem was sound and retained.There was notable corrosion found at the taper of the stem and the bore of the cobalt chrome head.There was moderate proliferative synovitis that appeared to be inflammatory.There was about a 30 cc turbid joint effusion.The capsule was partially detached posterior-inferior-lateral but was generally sound.The pathology report of the right hip tissue frozen section was notable for the histocytic synovitis appears to be a reaction to metal wear (metallosis).At about 10 months postoperatively on (b)(6) 2016, his random urine cobalt level was 1.3 ppb and blood cobalt level was 1.1 ppb.He still has a cobalt chrome right tka.Repeat fdg pet brain scan showed improved brain metabolism.Pt noted feeling significant improvement in cognitive function, improved mood, and lifting of his mental fog.Fda safety report id# (b)(4).

• Brand Name: ZIMMER DUROM METAL ON METAL HIP
• Type of Device: PROSTHESIS, HIP, FEMORAL, RESURFACING
• Manufacturer (Section D): ZIMMER INC.; warsaw IN
• MDR Report Key: 9396889
• MDR Text Key: 168840081
• Report Number: MW5091376
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2019
• 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?: 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: 65 YR
• Patient Weight: 81