MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL BASEPLATE-LM/RL-SZ 4; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Model Number 180615

Device Problem Fracture (1260)

Patient Problem Ambulation Difficulties (2544)

Event Date 10/30/2022

Event Type  malfunction  

Manufacturer Narrative

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.Device not returned.

Event Description

Patient complained of pain.Had x ray and discovered tibial baseplate fracture.

Manufacturer Narrative

Reported event: an event regarding crack/fracture involving a mako baseplate was reported.The event was confirmed through the images provided and a material analysis.Method & results: -product evaluation and results: visual inspection was performed as part of the material analysis report (mar), dated 19 june 2023.This inspection indicated: 'visual and stereo-microscope examination image depicted shows the tibial baseplate with fracture location highlighted by the arrow.Also included in the image are the femoral component and the tibial insert.On visual examination, the fracture was observed laterally through the baseplate.Bone cement was observed on the proximal surface of the femoral component and on the distal surface of the baseplate.Shows a stereo microscope image of the full fracture surface associated with the posterior side of the baseplate.Show higher magnification stereo microscope images of the fracture surfaces associated with the anterior and posterior sides of the baseplate, respectively.Based on macroscopic surface features observed, including river lines, the approximate origin location (o) was determined.' a material analysis has been performed.The report concluded: 'review of tibial baseplate, confirmed a fracture of the baseplate.Characterization using stereo microscopy and scanning electron microscopy confirmed fracture through the baseplate in fatigue.No manufacturing or material related defects were observed on the device surfaces examined' -clinician review: a review of the provided medical records by a clinical consultant indicated: conclusion of assessment: a fracture occurred of the tibial tray after a uni knee, the event will require revision surgery.The age of the implant is only 7 months.There was significant lucency beneath the tray that may indicate loosening or infection.Device or procedure related adverse event: tibial tray fracture.Root cause: a root cause cannot be determined from the material provided.-product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient was revised due to fracture of the tibial component.A review of the provided medical records by a clinical consultant indicated: a fracture occurred of the tibial tray after a uni knee, the event will require revision surgery.The age of the implant is only 7 months.There was significant lucency beneath the tray that may indicate loosening or infection.A material analysis concluded: review of tibial baseplate, confirmed a fracture of the baseplate.Characterisation using stereo microscopy and scanning electron microscopy confirmed fracture through the baseplate in fatigue.No manufacturing or material related defects were observed on the device surfaces examined'.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Patient complained of pain.Had x ray and discovered tibial baseplate fracture.

• Brand Name: MCK TIBIAL BASEPLATE-LM/RL-SZ 4
• 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; weston, FL 33331 ; 9546280700
• MDR Report Key: 15833402
• MDR Text Key: 303997393
• Report Number: 3005985723-2022-00151
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 00848486000783
• UDI-Public: 00848486000783
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Report Date: 07/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 180615
• Device Catalogue Number: 180604
• Device Lot Number: 26131218-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2019
• 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
• Patient Age: 56 YR
• Patient Sex: Male