MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK PATELLOFEMORAL-R-SZ 4; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY

Catalog Number 180414

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 07/28/2017

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other similar events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.

Event Description

Revised a mako pf and competitor uni of the right knee to a total knee primary triathlon; no use of augments.The original pf procedure was performed on (b)(6) 2011.Reason for revision was disease progression.Tourniquet was used.

Manufacturer Narrative

An event regarding revision due to patient factors (disease progression) involving a mako femoral component was reported.The event was not 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 that x-ray printouts, all undated, include an ap of bilateral knees, weightbearing, a pa of bilateral knees, patellar view of both knees, and a lateral of the right knee demonstrating bilateral medial unicompartmental knee arthroplasties and a right patellofemoral arthroplasty.The left knee components appear in nominal position, the right tibial component is subluxated laterally, and the right patella is tilted and subluxated on the patellar view.No patient demographics, no clinical or past medical history, no examination of explanted components, and no revision operative report or description of findings is available.Based upon the information available for review, there is no indication that factors related to the design, manufacturing or materials of the mako patellofemoral components were responsible for this revision of the right knee to a total knee arthroplasty six years after pfa surgery.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: it was reported that patient was revised due to disease progression and tourniquet was used.The event could not be confirmed nor the root cause determined because the devices were not returned for evaluation.The provided medical information was submitted to a consulting clinician who indicated that no patient demographics, no clinical or past medical history, no examination of explanted components, and no revision operative report or description of findings is available.Based upon the information available for review, there is no indication that factors related to the design, manufacturing or materials of the mako patellofemoral components were responsible for this revision of the right knee to a total knee arthroplasty six years after pfa surgery.No further investigation for this event is possible at this time.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.

Event Description

Revised a mako pf and competitor uni of the right knee to a total knee primary triathlon; no use of augments.The original pf procedure was performed on (b)(6) 2011.Reason for revision was disease progression.Tourniquet was used.

• Brand Name: MCK PATELLOFEMORAL-R-SZ 4
• Type of Device: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY
• 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: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6813392
• MDR Text Key: 83367143
• Report Number: 3005985723-2017-00387
• 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,Followup
• Report Date: 10/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2014
• Device Catalogue Number: 180414
• Device Lot Number: 14610209-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2011
• 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: 74 YR