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

Device Problem Insufficient Information (3190)

Patient Problem Inflammation (1932)

Event Type  Injury  

Manufacturer Narrative

Gasper, et al."complications following partial and total wrist arthroplasty: a single-center retrospective review." j hand surg am.Vol.41 (january 2016).Pg.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.No medical records received; however, it is noted that the cementless construct utilized in this article study is off-label use.Additionally, the use of the maestro in the distal radial hemiarthroplasty construct is not an indicated use.Initial reporter - authors of the article include jesse lou, patrick m.Kane, sidney m.Jacoby, a.Lee osterman, and randall w.Culp.This report is number 2 of 3 mdr's filed for the same patient (reference 1825034-2016-05336/0001825034 - 2017 - 00503/0001825034 - 2017 - 00507).

Event Description

It is reported in a journal article that a patient underwent radical flexor tenosynovectomy 28.9 months following wrist arthroplasty due to recurrent flexor tenosynovitis.No further information is available.

• Brand Name: UNKNOWN MAESTRO RADIAL COMPONENT
• 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: 6372535
• MDR Text Key: 68816599
• Report Number: 0001825034-2017-00503
• 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: 02/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2017
• 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: 02/01/2017
• 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; Other