MAUDE Adverse Event Report: MAKO SURGICAL CORP. UNKNOWN_JOINT REPLACEMENT_ROBOTICS_PRODUCT; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number UNK_OFL

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 03/15/2019

Event Type  Injury  

Manufacturer Narrative

As part of normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplemental report will be submitted when additional information becomes available.

Event Description

The doctor performed initial medial uka surgery on the patient's left knee and followed up with patient post-operatively.10-year follow-up of the patient occured on (b)(6) 2020.Information collected on patient reported: patient reported a revision to their medial uka.Reason for revision was pain and revision occured on (b)(6) 2019.

Event Description

The doctor performed initial medial uka surgery on the patient's left knee and followed up with patient post-operatively.10-year follow-up of the patient occured on (b)(6) 2020.Information collected on patient reported: patient reported a revision to their medial uka.Reason for revision was pain and revision occured on (b)(6) 2019.

Manufacturer Narrative

Reported event: an event regarding revision due to pain involving an unknown mako knee was reported.The event was not confirmed.Method & results:  -device evaluation and results: not performed as product was not returned.-clinician review: no medical records were received for review with a clinical consultant   -device history review: could not be performed as lot code information was not provided.  -complaint history review: could not be performed as lot code information was not provided.  conclusion: the event itself could not be confirmed and exact cause of the event could not be determined because insufficient information was provided.Further information such as device return, pre and post operative x-rays, operative reports as well as patient history and follow up notes are required to complete the investigation for determining a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Product surveillance will continue to monitor for trends.H3 other text : device not returned.

• Brand Name: UNKNOWN_JOINT REPLACEMENT_ROBOTICS_PRODUCT
• 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: 10554724
• MDR Text Key: 207565065
• Report Number: 3005985723-2020-00299
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_OFL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention