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U.S. Department of Health and Human Services

MAUDE Adverse Event Report:

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Device Problem Corroded (1131)
Patient Problem Host-Tissue Reaction (1297)
Event Type  Injury  
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
 
Event Description
It was reported that the patient was revised approximately 2 years post initial right hip surgery due to adverse local tissue reaction. Head and liner were revised. Corrosion was found at the base of the femoral head.
 
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MDR Report Key7562779
MDR Text Key109885033
Report Number0001822565-2018-02895
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 06/01/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/01/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/02/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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