MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD XP TIBIAL BEARING LEFT LATERAL; PROSTHESIS KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Scar Tissue (2060)

Event Date 02/24/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical products - vanguard xp tibial bearing left medial #195884 lot #265980.Vanguard xp interlok femur #195216 lot #396200.Vanguard xp interlok pri tibial tray #195757 lot #273090.(b)(4).Multiple mdr reports were filed for this event, please see associated reports: vanguard xp tibial bearing left medial - 0001825034-2017-08111.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 underwent a bearing revision and scar resection approximately 13 months post initial knee surgery.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.(b)(6).Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Review of the complaint history determined that no further action(s) is/are required.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 the patient underwent revision due to intra articular scar approximately 13 months post-implantation.Arthrotomy and poly exchange was performed.No further information has been provided.

• Brand Name: VANGUARD XP TIBIAL BEARING LEFT LATERAL
• 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: 6927812
• MDR Text Key: 88951929
• Report Number: 0001825034-2017-08110
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK132873
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 195814
• Device Lot Number: 641500
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2014
• 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): Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 78