MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK VANGUARD CR KNEE; PROSTHESIS, KNEE

Model Number N/A

Device Problems Malposition of Device (2616); Positioning Problem (3009)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

The product was not returned for evaluation due to unknown location.Reported event was unable to be confirmed due to limited information received from the customer.Device history and complaint history review was not performed due to limited information provided.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.Under "warnings," it states that "improper selection, placement, positioning, alignment and fixation of the implant components may result in unusual stress conditions which may lead to subsequent reduction in the service life of the prosthetic components".Following review, no new risks were identified.Literature: jacobs, ca, phd and christensen, cp md;factors influencing patient satisfaction two to five years after primary total knee arthroplasty, j arthroplasty (2014).Http://dx.Doi.Org/10.1016/j.Arth.2014.01.008.Zimmer biomet complaint: (b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2014-08869, 0001825034-2016-00733, and 0001825034-2017-08235/08236/08237.(b)(4).Product location unknown.

Event Description

Information was received based on review of a journal article entitled, ¿factors influencing patient satisfaction two to five years after primary total knee arthroplasty".A review of the article identified one (1) unknown patient that was treated for tibial component malalignment.There has been no further information provided and the patients outcome is unknown.Attempts have been made and no further information has been provided.

• Brand Name: UNK VANGUARD CR KNEE
• 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: 6931529
• MDR Text Key: 89083115
• Report Number: 0001825034-2017-08238
• Device Sequence Number: 1
• Product Code: MBH
• 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: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/09/2017

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNK VANGUARD CR KNEE
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2014
• 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