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

Device Problem Insufficient Information (3190)

Patient Problems Wound Dehiscence (1154); Erythema (1840)

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. However, the implants in this article were used in a cementless construct, and it is noted that the cementless construct is off-label 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 mdrs filed for the same patient (reference 0001825034-2016-05332/0001825034-2017-00516/0001825034-2017-00523).

Event Description

It is reported in a journal article that a patient underwent a wrist wound irrigation and debridement 4. 7 months post implantation due to the development of erythema and wound dehiscence with mild drainage following wrist arthroplasty revision procedure. No further information available.

• 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: 6373504
• MDR Text Key: 68861300
• Report Number: 0001825034-2017-00516
• 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?: No

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