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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN KNEE FEMORAL SLEEVE

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DEPUY ORTHOPAEDICS INC US UNKNOWN KNEE FEMORAL SLEEVE Back to Search Results
Catalog Number UNK KNEE FEMORAL SLEEVE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Pain (1994); No Code Available (3191)
Event Date 04/01/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
The literature article entitled, "distal femoral replacement for acute distal femoral fractures in elderly patients" written by clayton c. Bettin, md, john c. Weinlein, md, patrick c. Toy, md, and robert k. Heck, md published by journal of orthopaedic trauma accepted by publisher 1 april 2016 was reviewed. The article's purpose was to evaluate outcomes of a cemented modular rotating-hinge distal femoral endoprosthesis as a treatment option for elderly patients with distal femoral fractures. The implant system used was the lps limb preservation system (depuy). Data was compiled from 18 patients with average age of 77. 1 years (range 62-94). Eight patients died of unrelated causes. The article reports only 2 patients had "implant-related complications. " each patient is captured individually in linked complaints. The article does not report specify that patients received patella resurfacing and it does not report the manufacturer of the cement. This complaint captures patient l a (b)(6) year old female who experienced worsening knee pain and redness 4 weeks post surgery. The knee was aspirated and tested positive for infection. Surgical intervention was provided with debridement and irrigation along with placement of antibiotic beads while retaining components. Six days later another debridement and irrigation was performed along with exchange of modular components and new antibiotic beads. Femoral body and rotating hinge poly components were exchanged while retaining the well fixed femoral stem and tibial components. She was then put on suppressive minocycline indefinitely and returned 2 years later (admitting she stopped taking her antibiotics) with increasing pain and again tested positive for infection. Another revision surgery was performed with debridement and irrigation along with poly exchange and replacement of antibiotic beads. She was then treated successfully with oral suppressive antibiotics for additional 6. 3 years until her death.
 
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Brand NameUNKNOWN KNEE FEMORAL SLEEVE
Type of DeviceFEMORAL SLEEVE
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key9384050
MDR Text Key185197451
Report Number1818910-2019-118400
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 11/06/2019
1 Device was Involved in the Event
2 Patients were Involved in the Event: 1   2  
Date FDA Received11/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK KNEE FEMORAL SLEEVE
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 Received12/17/2019
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: 11/27/2019 Patient Sequence Number: 1
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