MAUDE Adverse Event Report: MAKO SURGICAL CORP. UNKNOWN_JOINT REPLACEMENT_ROBOTICS_PRODUCT; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number UNK_OFL

Device Problems Insufficient Information (3190); Missing Information (4053)

Patient Problem Unspecified Infection (1930)

Event Date 04/12/2018

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 that patient's right knee was revised due to infection.

Manufacturer Narrative

Reported event: an event regarding revision due to infection was reported.Method & results: device history review: product history review was not completed because a serial number was not reported.Complaint history: based on the device identification (pn 209999) the complaint databases were reviewed from 2011 to present for similar reported events regarding a revision of a partial knee procedure due to infection.There were no other reported events.Conclusion: device inspection could not be performed; no log files or session data was provided because the mps stated it was not available.

Event Description

It was reported that patient's right knee was revised due to infection.

• Brand Name: UNKNOWN_JOINT REPLACEMENT_ROBOTICS_PRODUCT
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 7475239
• MDR Text Key: 106966925
• Report Number: 3005985723-2018-00267
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• PMA/PMN Number: K170584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_OFL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 100