MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK PATELLOFEMORAL-R-SZ 3; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number	180413
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Arthritis (1723); Pain (1994); Injury (2348)
Date of Event	09/16/2019
Type of Reportable Event	Serious Injury
Additional 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 similar events for the lot referenced.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 patella resurfacing round dome-32 mm; cat# 180320-3; lot# 12151114-2.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
Revision of previous right mako pf replacement due to pain and progression of osteoarthritis.Initial surgery (b)(6) 2017.Revised with primary tkr.

• Brand Name: MCK PATELLOFEMORAL-R-SZ 3
• 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: 9185157
• Report Number: 3005985723-2019-00730
• Device Sequence Number: 16693287
• Product Code: NPJ
• UDI-Device Identifier: 00848486000486
• UDI-Public: 00848486000486
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K090763
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/14/2019

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 Catalogue Number: 180413
• Device Lot Number: 2405201-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2019
• Initial Report FDA Received Date: 10/14/2019
• 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 Weight: 66