MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK FEMORAL-RM-LL-SZ 2; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 180512

Device Problems Mechanical Problem (1384); Loss of Osseointegration (2408)

Patient Problems Pain (1994); Injury (2348); Inadequate Osseointegration (2646)

Event Date 04/25/2017

Event Type  Injury  

Manufacturer Narrative

An event regarding loosening involving a mako femoral component was reported.The event was confirmed.Method & results: -device evaluation and results: a visual, functional and dimensional inspection could not be performed as the device was not returned.-medical records received and evaluation: the provided medical information was submitted to a consulting clinician who indicated: "no patient demographics, no clinical or past medical history, no follow-up between november of 2012 and april of 2017, no serial x-rays, no revision operative report, and no examination of the explanted components are available.Reported outcomes of unicompartmental knee arthroplasty are not as good as total knee arthroplasty with the most common indication for conversion to total knee arthroplasty noted as progression of osteoarthritis to the other compartments and implant loosening.These are the likely causes of the bilateral conversions to total knee arthroplasties and are not shown to be related to factors of faulty unicompartmental knee arthroplasty component¿s design, manufacturing or materials." -device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.-complaint history review: there has been no other event for the lot referenced.Conclusions: the reported event was confirmed as per provided medical records reviewed by consulting clinician who indicated that most common indication for conversion to total knee arthroplasty noted as implant loosening.The progression of osteoarthritis noted as the likely cause of the event and is not shown to be related to factors of faulty unicompartmental knee arthroplasty component¿s design, manufacturing or materials.Further information such as patient demographics, clinical or past medical history, follow-up, serial x-rays, & revision operative report are needed to determine the root cause.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.

Event Description

The dr.Revised a bilateral mako medial uni patient to a total knee with a 5mm augment on each tibia.Original surgery was done (b)(6) 2012.This pi is for the right knee.Event update received: revision was due to pain.Nothing else was made available by the hospital.Update per medical review:x-ray printouts available for review include a series dated (b)(6) 2016, which is an ap of both knees, a patellar view of both knees, a lateral of the left knee, and a lateral of the right knee, demonstrating bilateral medial unicompartmental knee arthroplasties with bilaterally loose, subsided tibial components and radiolucencies behind both femoral components.

• Brand Name: MCK FEMORAL-RM-LL-SZ 2
• Type of Device: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
• 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6716081
• MDR Text Key: 80132556
• Report Number: 3005985723-2017-00307
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090763
• 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: 07/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 180512
• Device Lot Number: 26020312-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2012
• 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; Other; Required Intervention
• Patient Age: 56 YR