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

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Synovitis (2094)

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit conclusions as to the cause of the events.Event details and product identification were not provided for the patient mentioned in the journal article.The article was written by nydick, jason a.; greenberg, scott m.; stone, jeffrey d.; williams, bailee; polikandriotis, john a.; and hess, alfred v.

Event Description

It is reported that one patient developed synovitis as result of loose second metacarpal carpal non-locking screw.This required a synovectomy and screw removal.

• Brand Name: UNKNOWN MAESTRO TOTAL WRIST
• 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: 6258036
• MDR Text Key: 64988116
• Report Number: 0001825034-2017-00178
• 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: health professional,literatur
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/22/2016
• 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
• Patient Age: 67 YR