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

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Inflammation (1932); Synovitis (2094)

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. The following sections could not be completed with the limited information provided: b3 - date of event - ni d2 - device product code - ni d4 - expiration date - ni d6 - date implanted - ni d7 - date explanted - ni e1 - initial reporter - authors of the article include jesse lou, patrick m. Kane, sidney m. Jacoby, a. Lee osterman, and randall w. Culp. H4 - manufacture date ¿ ni this report is number 3 of 3 mdrs 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 a wrist arthroplasty revision and a radical flexor tenosyovectony 36. 1 months post-implantation due to symptomatic loosening of the radial component noted with signs of synovitis. The distal radial component was removed and replaced with competitor product. 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: 6372646
• MDR Text Key: 68820027
• Report Number: 0001825034-2017-00507
• 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

• 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?: Yes

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• 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 Treatment Data

Date Received: 03/02/2017 Patient Sequence Number: 1