MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER DUROM METAL ON METAL HIP DEVICE; PROSTHESIS, HIP, SEMI-CONTRAINED (METAL UNCEMENTED)

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

Patient Problems Tinnitus (2103); Toxicity (2333); Depression (2361); Shaking/Tremors (2515)

Event Date 01/12/2014

Event Type  Injury  

Event Description

Patient id: (b)(6) on (b)(6) 2007, he received a right total hip arthroplasty.It was a zimmer durom metal-on-metal hip device.On (b)(6) 2014, his serum/plasma cobalt level was 1.4 mcg/l.On (b)(6) 2015, his urine serum/plasma cobalt level was 0.71 mcg/l.On (b)(6) 2017, a urine cobalt was 1.7 mcg/l and a blood cobalt was 1.1 mcg/l.On (b)(6) 2019, urine cobalt was 3.0 mcg/l and the blood cobalt was 0.9 mcg/l.On (b)(6) 2020, his urine cobalt was 1.8 mcg/l and the blood cobalt was 1.0 mcg/l.In 2015, he began noticing a tremor in his hands.Around 2010, he experienced a sudden bout of depression, which resolved with medication, and is currently stable.About 2 years ago, he had issues of stiffness in the dominant right hand was prescribed plaquenil and mobic.He had a positive ana but testing has been negative for rheumatoid factor.He developed tinnitus about 2 years s/p r tha around the same time as his depression and is still a problem.Immunological and neurological problems are possibly suggestive of possible cobalt toxicity.He does not have any symptoms at the hip and will continue to be monitored.Fda safety report id # (b)(4).

• Brand Name: ZIMMER DUROM METAL ON METAL HIP DEVICE
• Type of Device: PROSTHESIS, HIP, SEMI-CONTRAINED (METAL UNCEMENTED)
• Manufacturer (Section D): ZIMMER, INC.; warsaw IN
• MDR Report Key: 9733291
• MDR Text Key: 180781891
• Report Number: MW5093111
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/14/2020

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: No Information
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/19/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Weight: 88