MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK FEMORAL-RM-LL-SZ 5; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 180515

Device Problem Malposition of Device (2616)

Patient Problems Pain (1994); Injury (2348)

Event Date 01/31/2018

Event Type  Injury  

Manufacturer Narrative

An event regarding pain involving a mako femoral component 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.Method and results: device evaluation and results: not performed as no product was returned for evaluation.Medical records received and 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 tricompartmental knee arthroplasty using a triathlon construct.Device history review: indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: 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.

Event Description

Surgeon revised patient on (b)(6) 2012 to a triathlon total knee primary cementless due to patient complaining of pain.Update 21 march 2018.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 tricompartmental knee arthroplasty using a triathlon construct.

• Brand Name: MCK FEMORAL-RM-LL-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
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer Contact: juana hiciano ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7437004
• MDR Text Key: 105719745
• Report Number: 3005985723-2018-00243
• 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
• Report Date: 04/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: 180515
• Device Lot Number: 26250212-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2012
• 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): Hospitalization; Required Intervention
• Patient Age: 42 YR