MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL ONLAY INSERT-SZ 3-9MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 180703-2

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 04/06/2016

Event Type  Injury  

Manufacturer Narrative

The following other device was also listed in this report: mck femoral-rm-ll-sz 2; cat# 180512; lot# 217745k/1.Mck tibial baseplate-rm/ll-sz 3; cat# 180613; lot# let1639850813.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.An evaluation of the device cannot be performed as the device was retained by the hospital 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

Dr.(b)(6) revised a mako uni knee patient that originally had a medial mako knee on (b)(6) 2014.Dr.Claimed the implants were not loose, he felt disease progression was the reason for revision.He said it was a primary tka.

Manufacturer Narrative

An event regarding patient factors involving a mako insert was reported.The event was confirmed.Method and results: device evaluation could not be performed as the subject device was not returned.Medical records received and evaluation: the provided medical records were reviewed by a consulting clinician who indicated "the most common reason for revising a unicondylar knee is progression of arthritis in the other knee compartments.There is no evidence that factors relating to the unicondylar component¿s design, manufacturing or materials were responsible for this clinical situation." device history review: 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: a review of the medical records by the clinician indicated "the most common reason for revising a unicondylar knee is progression of arthritis in the other knee compartments.There is no evidence that factors relating to the unicondylar component¿s design, manufacturing or materials were responsible for this clinical situation." the root cause of the reported revision surgery could not be determined due to the minimal information received.No further investigation for this event is possible at this time as no devices and insufficient information was received by stryker orthopedics.If devices and / or additional information become available, this investigation will be reopened.

Event Description

Dr.(b)(6) revised a mako uni knee patient that originally had a medial mako knee on (b)(6) 2014.Doctor claimed the implants were not loose, he felt disease progression was the reason for revision.He said it was a primary tka.

• Brand Name: MCK TIBIAL ONLAY INSERT-SZ 3-9MM
• 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: 5626021
• MDR Text Key: 44312261
• Report Number: 3005985723-2016-00137
• 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: 04/06/2016

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: 12/31/2018
• Device Catalogue Number: 180703-2
• Device Lot Number: 12050513-2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2016
• Initial Date FDA Received: 05/03/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2013
• 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): Required Intervention
• Patient Age: 62 YR