MAUDE Adverse Event Report: MAKO SURGICAL CORP. UNK MAKO KNEE; KNEE IMPLANT

Catalog Number UNK_OFL

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 10/31/2016

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be submitted when additional information becomes available.

Event Description

The surgeon performed a revision of the left knee because the patient was experiencing pain.

• Brand Name: UNK MAKO KNEE
• Type of Device: KNEE IMPLANT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer Contact: racquel aking ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6106775
• MDR Text Key: 60035208
• Report Number: 3005985723-2016-00389
• Device Sequence Number: 1
• Product Code: HSX
• 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: Physician
• Type of Report: Initial
• Report Date: 10/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_OFL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2016
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR