MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MAKO ROBOTIC ARM 3.1 STEREOTAXIC DEVICE, ROBOTICS

Model Number 219999

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Injection Site Reaction (4562)

Event Date 10/01/2020

Event Type  Injury  

Manufacturer Narrative

As part of normal complaint follow-up, an evaluation of the event has been initiated by mako surgical. A supplemental report will be submitted when additional information becomes available.

Event Description

It was reported through the submission of a revision usage sheet that the patient's right knee was revised. A 2x11 ts insert was implanted. Update 05/october/2020 wg: sales branch provided the primary usage sheet. A 2x9 ts insert was revised to a 2x11 ts insert. Update: "patient was treated with i&d due to acute infection. X-rays/removed polyethylene are not available. ".

• Brand Name: MAKO ROBOTIC ARM 3.1
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: joanne mahony ; ida industrial estate; carrigtwohill, NJ NA ; EI NA ; 2018315000
• MDR Report Key: 10762456
• MDR Text Key: 213878995
• Report Number: 3005985723-2020-00330
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 219999
• Device Catalogue Number: 219999
• 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: 01/20/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 10/30/2020 Patient Sequence Number: 1