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

Catalog Number UNK HIP FEMORAL STEM

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.

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 subcapital 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.

• Brand Name: UNKNOWN HIP FEMORAL STEM
• Type of Device: HIP FEMORAL STEM
• 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 Key: 9452673
• MDR Text Key: 170310912
• Report Number: 1818910-2019-122449
• 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: 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 Received: 12/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNK HIP FEMORAL STEM
• 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 Received: 01/14/2020
• 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