MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL ONLAY INSERT-SZ 3-8MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY

Catalog Number	180703-1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	08/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: mck patella resurfacing round dome-32 mm; cat# 180320-3; lot# 12370715-1.Mck patellofemoral-r-sz 2; cat# 180412; lot# 467482-m.Mck femoral-rm-ll-sz 2; cat# 180512; lot# 464706-m.Mck tibial baseplate-rm/ll-sz 3; cat# 180613; lot# 26371016-01.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Review of the product history records indicates products were manufactured and accepted into final stock with no reported discrepancies.There have been no other similar events for the lot referenced.There have been no other similar events for the sterile 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.
Event or Problem Description
It was reported that the surgeon performed a poly exchange of a patient's right knee due to possible infection.Procedure was completed successfully with no delay.

• Brand Name: MCK TIBIAL ONLAY INSERT-SZ 3-8MM
• Common Device Name: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 6859385
• Report Number: 3005985723-2017-00432
• Device Sequence Number: 10921865
• Product Code: NPJ
• UDI-Device Identifier: 00848486000851
• UDI-Public: 00848486000851
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K090763
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/12/2017

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: 12/28/2020
• Device Catalogue Number: 180703-1
• Device Lot Number: 12401015-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2017
• Initial Report FDA Received Date: 09/12/2017
• 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: 45 YR