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

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Swelling (2091); Synovitis (2094)

Event Type  Injury  

Manufacturer Narrative

Information received via published literature: michael p.Gasper- "complications following partial and total wrist arthroplasty: a single-center retrospective review" j hand surg am.Vol.41 (2016).47-53.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.Initial reporter/additional journal authors- jesse lou, patrick m.Kane, sidney m.Jacoby, a.Lee osterman, and randall w.Culp.

Event Description

Patient underwent total wrist arthroplasty.Subsequently, patient developed swelling consistent with synovitis 47 months postoperatively.Patient underwent an open complete wrist synovectomy 47.9 months after the initial procedure.During the procedure, the patient was tested for infection and determined to be positive for mycobacterium chelonae.A removal of hardware procedure was recommended.The patient underwent a revision 2.8 months later to remove all implants and place antibiotic cement spacers.

• Brand Name: UNKNOWN MAESTRO 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: 6339032
• MDR Text Key: 67702117
• Report Number: 0001825034-2017-00537
• 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: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2017
• 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: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention