MAUDE Adverse Event Report: MAKO SURGICAL CORP. TIBIAL BASEPLATE STD LM/RL SIZE 1; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 170601

Device Problem Insufficient Information (3190)

Patient Problem Bone Fracture(s) (1870)

Event Date 04/01/2019

Event Type  Injury  

Manufacturer Narrative

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.Device not returned.

Event Description

There has been only one incident related to a tibia fracture.This incident was a surgical error on behalf of the surgeon, and not related to the mako robot nor the mako implant.The incident was related to tibia fracture and not to implant fracture, and as i mentioned was due to surgical error, patient soft bone, and surgeon impaction technique.The surgeon recognized his mistake during the case, and make the correct adjustment on the fly to get the right outcomes.Case type: pka.Update: "the event is related to a intra-op bone fracture and not a revision.".

Manufacturer Narrative

An event regarding an intraoperative fracture of the tibia involving a mako baseplate was reported.The event was not confirmed.Method & results: product evaluation and results: not performed as no product was returned for evaluation.Clinician review: not performed as no medical records were received for review with a clinical consultant.Product history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: 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, primary operative reports as well as patient history and follow up notes are required to complete the investigation for determining a root cause.It is noted that the event description states that this incident was a surgical error on behalf of the surgeon, and not related to the mako robot nor the mako implant.The surgeon recognized his mistake during the case, and make the correct adjustment on the fly to get the right outcomes.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

1.There has been only one incident related to a tibia fracture.2.This incident was a surgical error on behalf of the surgeon, and not related to the mako robot nor the mako implant.3.The incident was related to tibia fracture and not to implant fracture, and as i mentioned was due to surgical error, patient soft bone, and surgeon impaction technique.The surgeon recognized his mistake during the case, and make the correct adjustment on the fly to get the right outcomes.Case type: pka.Update: "the event is related to a intra-op bone fracture and not a revision." update: left side.Patient was under anesthesia.Partial knee replacement procedure was converted to total knee replacement due to the resulting tibia fracture.45 minutes surgical delay.Update: "complainant have identified the devices that were in contact with the patient when the tibia fractured.Complainant confirmed and corrected the devices that were in contact with the patient when the tibia fractured.(updated on the catalog and the serial number as below ).A tourniquet used was not use.".

• Brand Name: TIBIAL BASEPLATE STD LM/RL SIZE 1
• 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: 8562094
• MDR Text Key: 143465472
• Report Number: 3005985723-2019-00321
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• PMA/PMN Number: K090763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/02/2019

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: 04/30/2021
• Device Catalogue Number: 170601
• Device Lot Number: 26040716
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/01/2019
• Initial Date FDA Received: 04/29/2019
• Supplement Dates Manufacturer Received: 06/10/2019
• Supplement Dates FDA Received: 07/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other