MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL ONLAY INSERT-SZ 6-8MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY

Catalog Number	180706-1
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Swelling (2091); Injury (2348)
Date of Event	07/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: mck femoral-lm-rl-sz 6; cat# 180506; lot# 473712-m; mck tibial baseplate-lm/rl-sz 6; cat# 180606; lot# 26130816-01.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.There have been no other events for the sterile lot referenced.It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.
Event or Problem Description
Patient had painful swollen knee.Pathology results concluded that the knee was infected.The tibial poly insert was removed, the knee was thoroughly irrigated, and a replacement poly liner was inserted.Two weeks after primary procedure.
Additional Manufacturer Narrative
An event regarding infection involving a mako insert was reported.The event was confirmed.Method & results: device evaluation and results: could not be performed as the subject device was not returned.Medical records received and evaluation: no patient medical records were available for review.Device history review: the devices were manufactured and accepted into final stock with no reported discrepancies complaint history review: there have been no other events for the lot or sterile lot referenced.Conclusions: the infection was clinically confirmed as per the reported event but a root cause could not be determined because the devices were not returned for evaluation and patient information, clinical history, and results of bloodwork for infection were not provided.A capa trend analysis was conducted for the reported failure mode and concluded infection may result from other factors not necessarily related to the device.No further investigation for this event is possible at this time as no devices and/or insufficient information was received by stryker orthopaedics.If devices and/or additional information become available, this investigation will be reopened.
Event or Problem Description
Patient had painful swollen knee.Pathology results concluded that the knee was infected.The tibial poly insert was removed, the knee was thoroughly irrigated, and a replacement poly liner was inserted.Two weeks after primary procedure.

• Brand Name: MCK TIBIAL ONLAY INSERT-SZ 6-8MM
• 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: 6772247
• Report Number: 3005985723-2017-00359
• Device Sequence Number: 13685999
• Product Code: NPJ
• UDI-Device Identifier: 00848486000943
• UDI-Public: 00848486000943
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2017

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: 03/11/2021
• Device Catalogue Number: 180706-1
• Device Lot Number: 12080316-1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/11/2017
• Supplement Date Received by Manufacturer: 09/13/2017
• Initial Report FDA Received Date: 08/07/2017
• Supplement Report FDA Received Date: 10/11/2017
• 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: 68 YR
• Patient Weight: 114