MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL BASEPLATE-RM/LL-SZ 7; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Model Number 180617

Device Problem Fracture (1260)

Patient Problems Ambulation Difficulties (2544); Insufficient Information (4580)

Event Date 07/18/2022

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

It was reported that the patient's right medial pka was converted to a tka due to a fractured baseplate which led to bowing of the insert.Patient's bmi was cited as a cause or contributing factor.Intra-operatively, the baseplate was found to be in 5 pieces.All components were revised.

Manufacturer Narrative

Reported event: an event regarding crack/fracture involving a mako baseplate was reported.The event was confirmed via evaluation of the provided photograph.Method & results: product evaluation and results: no product was returned for evaluation however a photograph was provided.The photograph shows the explanted devices.The baseplate is fractured into several pieces.Discoloration is visible on the insert.Bony ingrowth is present on the femoral component which appears unremarkable.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate 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: no product was returned for evaluation however a photograph was provided.The photograph shows the explanted devices.The baseplate is fractured into several pieces.Discoloration is visible on the insert.Bony ingrowth is present on the femoral component which appears unremarkable.The exact cause of the event could not be confirmed as insufficient information was provided.Further information such as device return, pre- and post-operative x-rays, 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.If additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

It was reported that the patient's right medial pka was converted to a tka due to a fractured baseplate which led to bowing of the insert.Patient's bmi was cited as a cause or contributing factor.Intra-operatively, the baseplate was found to be in 5 pieces.All components were revised.

Manufacturer Narrative

Reported event: an event regarding crack/fracture involving a mako baseplate was reported.The event was confirmed via evaluation of the provided photograph.Method & results: -product evaluation and results: no product was returned for evaluation however a photograph was provided.The photograph shows the explanted devices.The baseplate is fractured into several pieces.Discoloration is visible on the insert.Bony ingrowth is present on the femoral component which appears unremarkable.-clinician review: no medical records were received for review with a clinical consultant.-product history review: review of the device history records indicate 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: no product was returned for evaluation however a photograph was provided.The photograph shows the explanted devices.The baseplate is fractured into several pieces.Discoloration is visible on the insert.Bony ingrowth is present on the femoral component which appears unremarkable.The exact cause of the event could not be confirmed as insufficient information was provided.Further information such as device return, pre- and post-operative x-rays, 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.If additional information become available to indicate further evaluation is warranted, this record will be reopened.H3 other text : device not returned.

Event Description

It was reported that the patient's right medial pka was converted to a tka due to a fractured baseplate which led to bowing of the insert.Patient's bmi was cited as a cause or contributing factor.Intra-operatively, the baseplate was found to be in 5 pieces.All components were revised.

• Brand Name: MCK TIBIAL BASEPLATE-RM/LL-SZ 7
• Type of Device: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
• Manufacturer (Section D): MAKO SURGICAL CORP.; 3365 enterprise ave; weston FL 33331
• Manufacturer (Section G): MAKO SURGICAL CORP.; 3365 enterprise ave; weston FL 33331
• Manufacturer Contact: alessandra chavez ; 3365 enterprise ave; centennial park, elstree; weston, FL 33331 ; 9546280700
• MDR Report Key: 15174678
• MDR Text Key: 297331582
• Report Number: 3005985723-2022-00104
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 00848486000806
• UDI-Public: 00848486000806
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2023
• Device Model Number: 180617
• Device Catalogue Number: 180617
• Device Lot Number: 26370917-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2018
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 147 KG