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

Catalog Number 180416

Device Problems Unstable (1667); Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 06/16/2015

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device remained implanted in the patient and was not returned to the manufacturer.Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

Patient is complaining of unstable and sometimes painful patella/patella tracking.Right medial bicomp procedure was successfully completed on (b)(6) 2014.No patella issues were noted during surgery.

Manufacturer Narrative

An event regarding instability involving a mako patella was reported.The event was not confirmed.Method & results: -device evaluation and results: could not be performed as no items associated with the event were returned.-medical records received and evaluation: the provided medical records were reviewed by a consulting clinician who indicated based upon the information available for review, no determination can be made regarding the painful, unstable patellar tracking in this case.-device history review: a review of the device history records 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 event could not be confirmed nor the root cause determined because the devices were not returned for evaluation and insufficient medical information was provided.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.

Event Description

Patient is complaining of unstable and sometimes painful patella/patella tracking.Right medial bicomp procedure was successfully completed on (b)(6) 2014.No patella issues were noted during surgery.

• Brand Name: MCK PATELLOFEMORAL-R-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: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5075487
• MDR Text Key: 25717722
• Report Number: 3005985723-2015-00162
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2015
• Device Catalogue Number: 180416
• Device Lot Number: 14080810
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2010
• 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): Other
• Patient Age: 70 YR