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

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Pain (1994); Swelling (2091); Injury (2348)

Event Date 07/11/2017

Event Type  Injury  

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 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.

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 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
• Type of Device: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY
• 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: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6772247
• MDR Text Key: 82008924
• Report Number: 3005985723-2017-00359
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 00848486000943
• UDI-Public: 00848486000943
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K090763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 03/11/2021
• Device Catalogue Number: 180706-1
• Device Lot Number: 12080316-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/11/2017
• Initial Date FDA Received: 08/07/2017
• Supplement Dates Manufacturer Received: 09/13/2017
• Supplement Dates FDA Received: 10/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2016
• 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: 68 YR
• Patient Weight: 114