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

Catalog Number	180416
Medical Device Problem Codes	Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Arthritis (1723); Pain (1994); Injury (2348)
Date of Event	10/03/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 6989772
• Report Number: 3005985723-2017-00523
• Device Sequence Number: 19128403
• Product Code: NPJ
• UDI-Device Identifier: 00848486000516
• UDI-Public: 00848486000516
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K090763
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/09/2020
• Device Catalogue Number: 180416
• Device Lot Number: 459066-M
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/03/2017
• Supplement Date Received by Manufacturer: 11/30/2017
• Initial Report FDA Received Date: 10/31/2017
• Supplement Report FDA Received Date: 12/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 72 YR