MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD XP TOTAL KNEE SYSTEM FEMORAL COMPONENT; PROSTHESIS - KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Ambulation Difficulties (2544)

Event Date 12/02/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant products: cat#195250; lot#764390 - vngd xp inlk pri tib tray 73 mm, cat#195332; lot#867950 - vgxp xp e1 tib brg rl 9x71, cat#195402; lot#868520 - vgxp xp e1 tib brg rm 9x71.Related mfr reports: 0001825034-2017-10844, 0001825034-2017-10851, 0001825034-2017-10852.No product was returned; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies.This device is used for treatment a complaint history review for the same issue identified no complaints for the subject lot number.The concomitant components were reviewed for compatibility with no issues noted.Surgical notes were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.Without the opportunity to examine the complaint product, root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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.

Event Description

It was reported that following a procedure performed on (b)(6) 2013, the patient reported during a 6 month follow up that he experienced problems walking about, problems with washing/dressing self, problems with usual activities and severe pain.The patient reported using crutches or a walker at both the 3 month and 6 month post-op visits.

• Brand Name: VANGUARD XP TOTAL KNEE SYSTEM FEMORAL COMPONENT
• 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: 7154713
• MDR Text Key: 96048822
• Report Number: 0001825034-2017-10842
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK122160
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 195204
• Device Lot Number: 746990
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2013
• 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): Other
• Patient Age: 73 YR
• Patient Weight: 86