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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Injury (2348); No Code Available (3191)

Event Date 04/25/2017

Event Type  Injury  

Manufacturer Narrative

The following devices were also listed in this report: mck femoral-rm-ll-sz 2; cat# 180512; lot# 26020312-01.Mck tibial baseplate-rm/ll-sz 3; cat# 180613; lot# 26360412-01.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 not returned to the manufacturer.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 bilateral mako medial uni patient to a total knee with a 5mm augment on each tibia.Original surgery was done (b)(6) 2012 by dr.(b)(6).This pi is for the right knee.

Manufacturer Narrative

An event regarding loosening involving a mako insert was reported.Conclusion: there is no indication that the product reported in this investigation contributed to the event since provided medical records reviewed by consulting clinician indicated that patient was revised due to implant loosening.The insert is an integral part of the tibial component construct and will have to be explanted together with the loose baseplate and no other allegations were made against the insert.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Dr.(b)(6) revised a bilateral mako medial uni patient to a total knee with a 5mm augment on each tibia.Original surgery was done (b)(6) 2012 by dr.(b)(6).This pi is for the right knee.Event update received on 09-may-2017: revision was due to pain.Nothing else was made available by the hospital.

• 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: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6583546
• MDR Text Key: 75717412
• Report Number: 3005985723-2017-00228
• 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: 07/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/08/2017
• Device Catalogue Number: 180703-2
• Device Lot Number: 12330412-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2012
• 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: 56 YR