MAUDE Adverse Event Report: BIOMET ORTHOPEDICS VANGUARD 360 OSSEOTI TIBIAL SLEEVE AUGMENT- BIOMET 360 TIBIAL SM CRUCIATE WING; PROSTHESIS, KNEE

Catalog Number 185650

Device Problem Insufficient Information (3190)

Patient Problem Wound Dehiscence (1154)

Event Date 01/23/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical products - bmt 360 tib tray 75mm catalog #: 185204 lot # 029780, van ps open intl femlt 67.5 catalog #: 183130 lot #: j3903135, series a pat std 37 3peg catalog #: 184768 lot #: 666080, biomet smooth knee stems 12x40 catalog #: 145002 lot #: 592030, bmt 360 tib sm cruciate wing catalog #: 185650 lot#: 727410.The complaint device has not been returned, but the device investigation has not yet been completed.Once the evaluation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were reported for this event.0001825034-2017-04389, 0001825034-2017-04390, 0001825034-2017-04391, 0001825034-2017-04393, 0001825034-2017-04394.Remains implanted.

Event Description

It was reported that the patient underwent an irrigation and debridement eighteen days post implantation due to wound dehiscence and persistent drainage.During the procedure the patient's knee was manipulated.The surgeon does not believe the knee was infected.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no were trends identified.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.

• Brand Name: VANGUARD 360 OSSEOTI TIBIAL SLEEVE AUGMENT- BIOMET 360 TIBIAL SM CRUCIATE WING
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6675918
• MDR Text Key: 78653629
• Report Number: 0001825034-2017-04392
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK140883
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/23/2017

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: Physician
• Device Catalogue Number: 185650
• Device Lot Number: 727410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2017
• Initial Date FDA Received: 06/28/2017
• Supplement Dates Manufacturer Received: 09/07/2017
• Supplement Dates FDA Received: 09/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR