MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SEGMENT TAPER 60 MM PROSTHESIS, KNEE

Model Number N/A

Device Problems Fracture (1260); Unstable (1667); Material Twisted/Bent (2981)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/05/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4). Product has been received by zimmer biomet and the investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Femoral component item # 00585004202, lot # 63917932, multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-02669.

Event Description

It was reported that a patient underwent an initial right knee procedure; subsequently, 11 months later the patient tripped over his walker and a revision was needed due to his segmental distal femoral component had broken off and the other was bent. This also caused the patient to be unstable. Attempts have been made, and no further information has been provided.

• Brand Name: SEGMENT TAPER 60 MM
• 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: 8744045
• MDR Text Key: 149499329
• Report Number: 0001822565-2019-02670
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070978
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: 00585004606
• Device Lot Number: 64036543
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 01/10/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2018
• 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 Treatment Data

Date Received: 06/28/2019 Patient Sequence Number: 1