MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK FEMORAL-RM-LL-SZ 6; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 180516

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Injury (2348)

Event Date 07/14/2017

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.

Event Description

It was reported that patient's right knee was revised due to pain in the patellofemoral joint.A mako uni knee was revised to a total knee.

Manufacturer Narrative

An event regarding pain and revision involving a mako femoral component was reported.The event was not confirmed.Device evaluation and results: visual, dimensional and functional inspection were not performed as the item was not returned.Medical records received and evaluation: not performed as no medical records were received for review with a clinical consultant.Device history review: review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there has been no other event for this lot.The event could not be confirmed nor the root cause determined since the devices were not returned for evaluation and insufficient information was provided.A capa trend analysis was conducted for the reported failure mode and concluded pain may result from other factors not necessarily related to the device.Further information such as return of device, pre- and post-op xrays, office notes, operative reports, patient history, histopathology report and follow-up notes are needed to investigate this event further.If devices and/or additional information become available, this investigation will be reopened.

Event Description

It was reported that patient's right knee was revised due to pain in the patellofemoral joint.A mako uni knee was revised to a total knee.

• Brand Name: MCK FEMORAL-RM-LL-SZ 6
• 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: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6789989
• MDR Text Key: 82560992
• Report Number: 3005985723-2017-00372
• 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: 10/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 180516
• Device Lot Number: 26040615-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/14/2017
• Initial Date FDA Received: 08/11/2017
• Supplement Dates Manufacturer Received: 09/11/2017
• Supplement Dates FDA Received: 10/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2015
• 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: 76 YR