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 Death (1802); Unspecified Infection (1930); Unspecified Infection (1930); Pain (1994); Pain (1994); No Code Available (3191); 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.

Manufacturer Narrative

Medwatch closure : depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Device history lot : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• 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
• 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
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 11/06/2019

1 Device was Involved in the Event

2 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK KNEE FEMORAL SLEEVE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/06/2019
• Initial Date FDA Received: 11/27/2019
• Supplement Dates Manufacturer Received: 12/17/2019
• Supplement Dates FDA Received: 12/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 0
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR