MAUDE Adverse Event Report: MAKO SURGICAL CORP. MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 5 - 8 MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 180735-1

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Injury (2348)

Event Date 04/18/2019

Event Type  Injury  

Manufacturer Narrative

The following devices were also listed in this report: mck tibial baseplate-lm/rl-sz 5 catalogue number -180605 lot number - 26470917-01.Mck femoral-lm-rl-sz 5 - catalogue number - 180505 lot number - 549084-m.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.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 Description

The doctor performed an i&d poly exchange on a mako partial knee due to infection.Original surgery was (b)(6) 2018.The i&d was performed on the (b)(6) 2018.On the 22/april/2019 the rep provided implant/ usage sheets for primary and subsequent two revisions and reported that no further information will be released by the hospital or surgeon.

Event Description

The doctor performed an i&d poly exchange on a mako partial knee due to infection.Original surgery was (b)(6) 2018.The i&d was performed on the (b)(6) 2018.On the (b)(6) 2019 the rep provided implant/ usage sheets for primary and subsequent two revisions and reported that no further information will be released by the hospital or surgeon.

Manufacturer Narrative

Reported event: an event regarding infection involving a mako insert was reported.The event was not confirmed.Method & results: product evaluation and results: could not be performed as the device was not returned.Medical records received and evaluation: could not be performed as no medical records were returned for review.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there were no other events for the lot and sterile lot provided.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time as no devices and insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.Product surveillance will continue to monitor for trends.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product nonconformity or unanticipated hazard.

• Brand Name: MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 5 - 8 MM
• Type of Device: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8619526
• MDR Text Key: 145369593
• Report Number: 3005985723-2019-00366
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 00848486016548
• UDI-Public: 00848486016548
• Combination Product (y/n): N
• PMA/PMN Number: K150307
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 180735-1
• Device Lot Number: TKOP27
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention