MAUDE Adverse Event Report: ZIMMER INC. TOTAL HIP REPLACEMENT; HIP, PROSTHESIS

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

Patient Problems Tinnitus (2103); Toxicity (2333); Loss of consciousness (2418)

Event Type  No Answer Provided  

Event Description

High cobalt and chromium reading due to hip replacement.Have had memory problems, troubled thought processing, tinnitus, passed out.Neurologist had me get in touch with orthopedic surgeon.He is commending removal.

• Brand Name: TOTAL HIP REPLACEMENT
• Type of Device: HIP, PROSTHESIS
• Manufacturer (Section D): ZIMMER INC.
• MDR Report Key: 7938391
• MDR Text Key: 123129030
• Report Number: MW5080362
• Device Sequence Number: 1
• Product Code: KWY
• 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: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/04/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 70