MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VNGD XP INLK PRI TIB TRAY 79MM; PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 04/08/2014

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint- (b)(4).Concomitant medical products: part 195204, lot 999140- vgxp intlk fmrl rt 62.5, part 195339, lot 868070- vgxp xp e1 tib brg rl 9x79, part 195409, lot 868650- vgxp xp e1 tib brg rm 9x79.Customer has indicated that the product will not be returned to zimmer biomet for investigation.Multiple mdr reports were filed for this event, please see associated reports: mfr 0001825034-2018-01193, mfr 0001825034-2018-01195, mfr 0001825034-2018-01196.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies related to the complaint were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.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.This report is being submitted late as it has been identified in remediation.

Event Description

Clinical study 504 - extreme pain post-surgery.

• Brand Name: VNGD XP INLK PRI TIB TRAY 79MM
• 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: 7288093
• MDR Text Key: 100649815
• Report Number: 0001825034-2018-01194
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK122160
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 195252
• Device Lot Number: 928810
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2015
• Initial Date FDA Received: 02/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2013
• 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): Other
• Patient Age: 62 YR
• Patient Weight: 71