MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK PATELLOFEMORAL-R-SZ 6; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 180416

Device Problems Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Arthritis (1723); Pain (1994); Injury (2348)

Event Date 10/03/2017

Event Type  Injury  

Manufacturer Narrative

Review of the product history records indicate the products were manufactured and accepted into final stock with no reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

Event Description

Patient had a primary procedure for the medial aspect on (b)(6) 2015.Patient had another procedure for the lateral and pf aspects on (b)(6) 2016 (no stryker devices were explanted at that time).All components except the patella component were explanted on (b)(6) 2017.Revision was performed due to pain.

Manufacturer Narrative

An event regarding revision due to pain involving a mako patellofemoral component was reported.The event was confirmed.Device evaluation and results: could not be performed as the device was not returned.Medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated: osteoarthritis disease progress after medial unicompartmental knee arthroplasty (uka) surgery in 2015 has contributed to a second procedure of lateral and patellofemoral uka in 2016 instead of a preferable conversion to total knee with malalignment after the second uka intervention contributing to overload with clinical symptoms requiring still conversion to a total knee in 2017.Device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.There has been no other event for the lot referenced.A review of the provided medical records and x-rays by a clinical consultant indicated that osteoarthritis disease progress after medial unicompartmental knee arthroplasty (uka) surgery in 2015 has contributed to a second procedure of lateral and patellofemoral uka in 2016 instead of a preferable conversion to total knee with malalignment after the second uka intervention contributing to overload with clinical symptoms requiring still conversion to a total knee in 2017.It is noted that the combination of medial and lateral uka is off-label as per ifu reference, (b)(4).If additional information and/or device becomes available, this investigation will be reopened.

Event Description

Patient had a primary procedure for the medial aspect on (b)(6) 2015.Patient had another procedure for the lateral and pf aspects on (b)(6) 2016 (no stryker devices were explanted at that time).All components except the patella component were explanted on (b)(6) 2017.Revision was performed due to pain.

• Brand Name: MCK PATELLOFEMORAL-R-SZ 6
• 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: timothy rice ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6989772
• MDR Text Key: 90636731
• Report Number: 3005985723-2017-00523
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 00848486000516
• UDI-Public: 00848486000516
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/09/2020
• Device Catalogue Number: 180416
• Device Lot Number: 459066-M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2015
• 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: 72 YR