MAUDE Adverse Event Report: BIOMET ORTHOPEDICS BIOMET AGC V2 INTERLOK TIBIAL 22X 67MM; PROSTHESIS, KNEE

Catalog Number 158487

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Information (3190)

Event Date 05/16/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This device is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet manufactures a similar device that is cleared or distributed in the united states under 510(k) number k921182.The customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent an initial knee procedure.During the surgery, it was discovered that the sterile packaging had some kind of substance on it.The surgery was delayed for one hour due to the concern of sterility of the device.No adverse events have been reported as a result of the malfunction.

• Brand Name: BIOMET AGC V2 INTERLOK TIBIAL 22X 67MM
• 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: 6649011
• MDR Text Key: 77936250
• Report Number: 0001825034-2017-04098
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PSEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 158487
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization