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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL HEAD

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DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL HEAD Back to Search Results
Catalog Number UNK HIP FEMORAL HEAD
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Date 03/20/2006
Event Type  Death  
Manufacturer Narrative
Product complaint # (b)(4). Report source is a literature article. There is limited information regarding the reported death. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(4).
 
Event Description
The literature article entitled, "fatal cerebral emboli in the absence of a cardiac arterial-venous shunt" written by jennifer tucker ammon, md, cyna khalily, md, and d. Kevin lester, md published by the journal of arthroplasty vol. 22 no. 3 2007 accepted by publisher 20 march 2006 was reviewed. The article's purpose was to report on one case report of a (b)(6) year old mentally delayed female who underwent a cementless bipolar hemiarthroplasty for treatment of a displaced subcaptial femoral neck fracture. A depuy femoral stem and femoral head was utilized. Intraoperatively she remained hemodynamically stable and well perfused with oxygen levels throughout operation. Six hours post op the patient had not awakened from surgery. Mri imaging revealed 22 fat emboli. She did not regain previous consciousness or function and 10 months later she died because of severe generalized debilitation.
 
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Brand NameUNKNOWN HIP FEMORAL HEAD
Type of DeviceHIP FEMORAL HEAD
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
JTE WARSAW MFG SITE
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key9452643
MDR Text Key170305026
Report Number1818910-2019-122450
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
Source Type health professional,literatur
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK HIP FEMORAL HEAD
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/14/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/11/2019 Patient Sequence Number: 1
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