MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK PATELLOFEMORAL-L-SZ 4; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 180404

Device Problem Insufficient Information (3190)

Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Date 09/16/2015

Event Type  Injury  

Manufacturer Narrative

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) performed a revision surgery.He revised a patient that had a left knee mako pf replacement on (b)(6) 2014 to an exactech cemented primary total knee due to disease progression to the medial and lateral compartments.

Manufacturer Narrative

An event regarding a revision surgery involving a mako patella component was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as the device was not returned.Medical records received and evaluation: "there is no evidence that the conversion of the patellofemoral arthroplasty to a total knee arthroplasty due to progression of arthritis was related to factors of faulty patellofemoral design, manufacturing or materials." device history review: the reported device was manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events reported for this manufacturing lot.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) performed a revision surgery.He revised a patient that had a left knee mako pf replacement on (b)(6) 2014 to an exactech cemented primary total knee due to disease progression to the medial and lateral compartments.

• Brand Name: MCK PATELLOFEMORAL-L-SZ 4
• 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 navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5147180
• MDR Text Key: 28142121
• Report Number: 3005985723-2015-00195
• 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: Followup
• Report Date: 09/16/2015

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 Catalogue Number: 180404
• Device Lot Number: 26080912-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/14/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 75 YR