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

Catalog Number 180705

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Injury (2348)

Event Date 01/31/2018

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other events for the reported lot.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.The following devices were also listed in this report: mck femoral-rm-ll-sz 5, cat# 180515, lot# 26250212-01; mck tibial baseplate-rm/ll-sz 5, cat# 180615, lot# 26030512-01.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

Event Description

Doctor revised a medial uni knee originally done on (b)(6) 2012 to a triathlon total knee primary cementless due to patient complaining of pain.

Event Description

Doctor revised a medial uni knee originally done on (b)(6) 2012 to a triathlon total knee primary cementeless due to patient complaining of pain.Update: based on the medical review: natural degenerative disease progress in the patellofemoral joint with additional varus malposition of the restoris uka device contributing to an overload condition in the medial uka section have in concert contributed to an overload condition with pain requiring exchange of the medial uka for tri-compartmental knee arthroplasty using a triathlon construct.

Manufacturer Narrative

An event regarding pain involving a mako insert was reported.Based on a medical review the pain reported was a result of degenerative disease progress in the patellofemoral joint with additional varus malposition of the restoris uka device.Device evaluation and results: not performed as no product was returned for evaluation.The medical review concluded: natural degenerative disease progress in the patellofemoral joint with additional varus malposition of the restoris uka device contributing to an overload condition in the medial uka section have in concert contributed to an overload condition with pain requiring exchange of the medial uka for tri-compartmental knee arthroplasty using a triathlon construct.Device history review: indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.The medical review concluded: natural degenerative disease progress in the patellofemoral joint with additional varus malposition of the restoris uka device contributing to an overload condition in the medial uka section have in concert contributed to an overload condition with pain requiring exchange of the medial uka for tricompartmental knee arthroplasty using a triathlon construct.No further investigation for this event is possible at this time.If devices and/or additional information become available, this investigation will be reopened.

• Brand Name: TIBIAN INSERT ONLAY SZ 5
• Type of Device: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 7304025
• MDR Text Key: 101232389
• Report Number: 3005985723-2018-00100
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• PMA/PMN Number: K090763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 04/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Catalogue Number: 180705
• Device Lot Number: 1214111-1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 42 YR