MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD TIBIAL AUGUMENT WITH BOLTS; PROSTHESIS KNEE

Model Number N/A

Device Problems Degraded (1153); Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 03/27/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned because it was discarded.The investigation is in process.Once the investigation  has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that as a vanguard knee system was prepared for implantation when the equipment was assembled for the implant, a bolt was noted to be missing the threads necessary to secure the piece.It is unclear if user error was involved when assembling the system or not.The product representative had to locate another set before the procedure could proceed.This resulted in a 40 minute delay in the procedure and the patient had an extended time under anesthesia.The procedure was completed and the procedure was successful.The patient was unharmed.

Manufacturer Narrative

(b)(4).The reported event could not be confirmed based on limited information received.No products were returned; therefore, the visual and dimensional inspections were not performed.Device history record (dhr) was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.A definitive root cause cannot be determined with the information provided.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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 during a total knee arthroplasty revision procedure, while preparing and assembling the tibial component and an augment, the bolt threads had stripped.Surgeon wanted to use a bigger augment, however the existing augment could not be removed due to the bolt damage.A new tibial component and augment were located, assembled, and implanted to complete the procedure.There was an extension to surgical time of approximately 40-45 minutes due to the issue.There was no patient harm as a result.

• Brand Name: VANGUARD TIBIAL AUGUMENT WITH BOLTS
• 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: 7203680
• MDR Text Key: 97715197
• Report Number: 0001825034-2018-00348
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK093293
• 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: 02/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 185233
• Device Lot Number: 088740
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2013
• 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): Hospitalization; Other
• Patient Age: 68 YR