MAUDE Adverse Event Report: MAKO SURGICAL CORP. UNKNOWN MEDIAL UKA, INLAY; KNEE IMPLANT

Catalog Number UNK_OFL

Device Problem Osseointegration Problem (3003)

Patient Problems Injury (2348); Inadequate Osseointegration (2646)

Event Date 01/24/2019

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

This pi is for the joint replacement implants.Information received from sales rep on (b)(6) 2019: upon review by joint replacement research for the surgeon's payment, patients were noted to have had their implant knee removed, revised, or re-operated on.Reporter has indicated she does not have access to any additional information as the reporting site takes on all regulatory responsibilities, and all data is de-identified.This pi is for a revision due to tibial loosening, whereby tibial component & insert exchange after approximately 5 years of implantation.

• Brand Name: UNKNOWN MEDIAL UKA, INLAY
• 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: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8357639
• MDR Text Key: 136744459
• Report Number: 3005985723-2019-00168
• Device Sequence Number: 1
• Product Code: HRY
• 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,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_OFL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2019
• 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: 71 YR