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

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.

• Brand Name: UNKNOWN KNEE FEMORAL SLEEVE
• Type of Device: FEMORAL 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 Key: 9384050
• MDR Text Key: 185197451
• Report Number: 1818910-2019-118400
• 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: 11/06/2019

1 Device was Involved in the Event

• 2 Patients were Involved in the Event: 1 2
• Date FDA Received: 11/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNK 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 Received: 12/17/2019
• 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