MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD COMPLETE KNEE SYSTEM; PROSTHESIS - KNEE

Model Number N/A

Device Problem Malposition of Device (2616)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Pelt, c.E; gililland, j.M.; doble, j.; stronach, b.M.; peters, c.L.(2013) hybrid total knee arthroplasty revisited: midterm followup of hybrid versus cemented fixation in total knee arthroplasty.(b)(6).(b)(6).The product was not available to be returned.Root cause could not be determined.Condition is addressed in the package insert.Part and lot identification necessary for review of device history records, and complaint history was not provided.Risks associated with reported condition are addressed through the warnings in the package insert as a part of design control risk management.Associated package insert (b)(4), there are warnings in the package insert that state that this type of event can occur, under possible adverse effects, number 4 it states, "loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption or excessive activity." if any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.(b)(4).

Event Description

Information was received based on review of a journal article titled, "hybrid total knee arthroplasty revisited: midterm followup of hybrid versus cemented fixation in total knee arthroplasty¿.The article identified seven (7) revisions of either the tibial or femoral component were performed in the hybrid tkas group for aseptic causes, an unidentified number of which were performed due to malalignment complications.

• Brand Name: VANGUARD COMPLETE KNEE SYSTEM
• Type of Device: PROSTHESIS - KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6928009
• MDR Text Key: 89077452
• Report Number: 0001825034-2017-08130
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNK VANGUARD
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2014
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention