MAUDE Adverse Event Report: ZIMMER INC. ZIMMER DUROM METASAL; PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT)

Device Problem Output Problem (3005)

Patient Problems Tinnitus (2103); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/01/2022

Event Type  Injury  

Event Description

Bilateral metal on metal hip replacement in 2007 (zimmer durom).Metal ion levels monitored.Chromium 2.4 mcg/l; cobalt 10.6 mcg/l.Have consistently generally been at these levels.Have begun to develop tinnitus 24/7.A symptom/result of elevated/toxic cobalt levels in bloodstream.Concerned about my long term health.In excess of normal range.Fda safety report id #(b)(4).

• Brand Name: ZIMMER DUROM METASAL
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT)
• Manufacturer (Section D): ZIMMER INC.
• MDR Report Key: 15667866
• MDR Text Key: 302492706
• Report Number: MW5112824
• Device Sequence Number: 2
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/20/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/24/2022
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White