MAUDE Adverse Event Report: BIOMET ORTHOPEDICS MAESTRO CAPITATE STEM 6X12MM; PROSTHESIS, WRIST

Model Number N/A

Device Problem Compatibility Problem (2960)

Patient Problem No Information (3190)

Event Date 04/21/2016

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly.Review of part numbers involved in the event found the capitate stem initially implanted is from an older system.This stem is incompatible with the carpal plate and carpal head, which are from a newer design of the system.There are warnings in the package insert that state that this type of event can occur: under warnings, number 1 states, "improper selection, placement, positioning, alignment and fixation of the implant components may result in unusual stress conditions which may lead to subsequent reduction in the service life of the prosthetic components." this report is number 1 of 3 mdr's filed for the same patient (reference 1825034-2016-01683 / 01685).Product location unknown.

Event Description

During a procedure, the surgeon was unable to assemble the capitate stem, carpal plate, and carpal head.The capitate stem and carpal plate were implanted without the carpal head.There was a thirty minute delay in procedure.The patient subsequently underwent a procedure five days later to remove and replace the plate and stem and implant a head.

• Brand Name: MAESTRO CAPITATE STEM 6X12MM
• 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: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 5671074
• MDR Text Key: 45668121
• Report Number: 0001825034-2016-01683
• Device Sequence Number: 1
• Product Code: JWJ
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: PK042032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 180120
• Device Lot Number: 181460
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2011
• 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