MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL COMPONENT PRECOAT LEFT MEDIAL/RIGHT LATERAL SIZE 4; PROSTHESIS KNEE

Model Number N/A

Device Problem Scratched Material (3020)

Patient Problem No Information (3190)

Event Date 12/13/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.(b)(4).Concomitant medical products: 00584201301, femoral component, lot 63668791, 00584202408, articular surface size 4 8 mm, lot 63850362, 00584305201, tibial tray, lot 64088641.Event occurred in (b)(6).

Event Description

It was reported that during a primary tka, the physician noted fine scratches to the proximal surface of the tibial tray.The device was implanted as there were no back ups available.Attempts have been made and no further information has been provided.

• Brand Name: TIBIAL COMPONENT PRECOAT LEFT MEDIAL/RIGHT LATERAL SIZE 4
• 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: 8254237
• MDR Text Key: 133325581
• Report Number: 0001822565-2019-00149
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K033363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00584200401
• Device Lot Number: 63775797
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2017
• 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