MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN MAESTRO TOTAL WRIST CARPAL HEAD; PROSTHESIS, WRIST

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 2 states, "early or late postoperative infection and/or allergic reaction." the following section could not be completed with the limited information provided.Date of event - ni.Device product code - ni.Expiration date - ni.Date explanted - ni.Manufacture date - ni.This report is number 7 of 8 mdrs filed for the same patient (reference 1825034-2017-01283 / 01288, 1825034-2016-05448, and 1825034-2017-00432).

Event Description

It was reported the patient underwent revision total wrist arthroplasty 19 days post-implantation due to infection.Subsequently, the patient underwent an additional revision due to infection within one month of the first revision.All products were removed.

• Brand Name: UNKNOWN MAESTRO TOTAL WRIST CARPAL HEAD
• Type of Device: PROSTHESIS, WRIST
• 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: 6375945
• MDR Text Key: 69014104
• Report Number: 0001825034-2017-01287
• Device Sequence Number: 1
• Product Code: JWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PNI
• 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
• Report Date: 03/01/2017

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 Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2017
• Initial Date FDA Received: 03/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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