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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPEDICS, INC. DEPUY HIP PROSTHESIS, HIP, SEMI-CONSTRAINED METAL POLYMER, CEMENTED

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DEPUY ORTHOPEDICS, INC. DEPUY HIP PROSTHESIS, HIP, SEMI-CONSTRAINED METAL POLYMER, CEMENTED Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Toxicity (2333)
Event Date 10/22/2018
Event Type  Injury  
Event Description
Eleven and half years ago i had a metal on metal hip replacement (depuy). Over the years my cobalt levels rose to a 5. On the above mentioned date, i had it fixed. In the last five months the cobalt has drained out of my system and my chromium is at a. 9. What bothers me is the initial dr who put the replacement in never followed up to tell me or anyone else that there is a problem. I know there are more than 1 million people in the us who could benefit mentally and physically if they insisted, as i did, on getting their blood tested several times each year. This is not something that is initiated by drs. I feel blessed that i have the moxie to take my healthcare into my own hands. I know there are scores of others who do not know to do this. On (b)(6) 2007 initial hip replacement, (b)(6). On (b)(6) 2018 hip replacement. I have two hip replacements.
 
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Brand NameDEPUY HIP
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED METAL POLYMER, CEMENTED
Manufacturer (Section D)
DEPUY ORTHOPEDICS, INC.
MDR Report Key8439712
MDR Text Key139535060
Report NumberMW5085056
Device Sequence Number1
Product Code JDL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 03/19/2019
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received03/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 03/20/2019 Patient Sequence Number: 1
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