MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN VANGUARD BEARING; PROSTHESSI KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Thrombosis (2100)

Event Date 09/12/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical products - vanguard cr femoral interlok - #183030 lot # j3960489.Vanguard series a standard patella - #184766 lot #868850.Vanguard mono finned stemmed tibial tray - #166521 lot # 6026023.Report source: (b)(6).Study - (b)(6) (543).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-09002.0001825034-2017-09113.It is unknown if product will be returning to zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient was experiencing venous thrombosis four months post initial knee surgery.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined that there is no separate bearing in this event.The initial report should be voided as it was submitted in error.The bearing is part of the tibial plate which is reported in 3002806535-2018-00191.

• Brand Name: UNKNOWN VANGUARD BEARING
• Type of Device: PROSTHESSI 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: 6964788
• MDR Text Key: 89834245
• Report Number: 0001825034-2017-09003
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2018
• 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
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 64