MAUDE Adverse Event Report: COBALT CHROME HIP; PROSTHESIS, HIP

COBALT CHROME HIP; PROSTHESIS, HIP

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

Patient Problem Toxicity (2333)

Event Date 09/11/2018

Event Type Injury

Event Description

Received cobalt chrome hip replacement in 2006, hip revision (b)(6) 2019 due to elevated levels of cobalt (7.3 ng).Fda safety report id# (b)(4).

1 Device was Involved in the Event
Brand Name	COBALT CHROME HIP
Type of Device	PROSTHESIS, HIP
MDR Report Key	8591545
MDR Text Key	144666562
Report Number	MW5086470
Device Sequence Number	1
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	05/04/2019
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
Was Device Available for Evaluation?	Yes
Initial Date Manufacturer Received	Not provided
Initial Date FDA Received	05/07/2019
Was Device Evaluated by Manufacturer?	No Information
Type of Device Usage	N
Patient Sequence Number	1
Patient Outcome(s)	Hospitalization; Required Intervention; Disability;
Patient Age	59 YR
Patient Weight	86