MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN TIBIAL TRAY FIXED BEARING SIZE 4; PROSTHESIS, KNEE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Ambulation Difficulties (2544); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10 medical devices: nexgen femoral component precoat size d left catalog#: 00595001401, lot#: 62507708.Nexgen articular surface size yellow/c-h 10 mm height catalog#: 00595203010, lot#: 62815614.Nexgen all poly patella standard size 35 mm diameter 9.0 mm catalog#: 00597206635, lot#: 62928274.Stryker bone cement part#: ni, lot#: ni.Stryker bone cement part#: ni, lot#: ni.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that patient underwent a left total knee arthroplasty.Patient reported pain, swelling, and instability since the initial procedure.Approximately nine years post-implantation, the patient underwent an aspiration procedure to check for infection and then an ultrasound to check for blood clots.A ten degree malformation was noted during the ultrasound.No further intervention has been reported.

• Brand Name: NEXGEN TIBIAL TRAY FIXED BEARING SIZE 4
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19116568
• MDR Text Key: 340284086
• Report Number: 0001822565-2024-01256
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072160
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2024
• 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: 00595403702
• Device Lot Number: 62828605
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/03/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female