MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL ONLAY INSERT-SZ 5-9MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 180705-2

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

Patient Problem Pain (1994)

Event Date 11/19/2015

Event Type  Injury  

Manufacturer Narrative

The following other devices were also listed in this report: mck tibial baseplate-lm/rl-sz 5; cat# 180605; lot# 26080114-01.Mck femoral-lm-rl-sz 5; cat# 180505; lot# 26031213-01.It cannot be determined which, if any of these devices may have caused or contributed to the patient's pain.An evaluation of the device cannot be performed as the device was discarded 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.Not returned to the manufacturer.

Event Description

Dr.(b)(6) converted a left knee medial mako to a tka.Original date of surgery was (b)(6) 2014.He said patient complained of persistent knee pain after original surgery.He said components were fixed securely and were in a good position, but the patient still complained of pain.

Manufacturer Narrative

An event regarding revision due to pain involving a mck tibial onlay insert-sz 5-9mm was reported.The event was not confirmed.Device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: a complaint history review was not performed as no device specific failure modes were identified.Conclusions: the investigation concluded that the exact cause of the event could not be determined because further information such as pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes and the return of the devices are needed to complete the investigation.It was also concluded that there is no indication the event is related to a manufacturing issue.No further investigation for this event is possible at this time.If devices and/or additional information become available, this investigation will be reopened.

Event Description

Dr.(b)(6) converted a left knee medial mako to a tka.Original date of surgery was (b)(6) 2014.He said patient complained of persistent knee pain after original surgery.He said components were fixed securely and were in a good position, but the patient still complained of pain.

• Brand Name: MCK TIBIAL ONLAY INSERT-SZ 5-9MM
• 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: 5302805
• MDR Text Key: 33653870
• Report Number: 3005985723-2015-00303
• 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: 11/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/30/2018
• Device Catalogue Number: 180705-2
• Device Lot Number: 12130313-3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2013
• 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: 55 YR