MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL BASEPLATE-RM/LL-SZ 5; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Model Number 180615

Device Problem Fracture (1260)

Patient Problem Fall (1848)

Event Date 11/01/2021

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 knee was converted from a pka to a tka due to a broken tibial baseplate.Surgeon reported possible contributing factor is that the patient is prone to falling.The femoral component, insert, and baseplate were revised.Rep confirmed there are no allegations against the revised insert or femoral component.

Event Description

It was reported that the patient's right knee was converted from a pka to a tka due to a broken tibial baseplate.Surgeon reported possible contributing factor is that the patient is prone to falling.The femoral component, insert, and baseplate were revised.Rep confirmed there are no allegations against the revised insert or femoral component.

Manufacturer Narrative

Reported event: an event regarding crack/fracture involving a mako baseplate was reported.The event was confirmed via evaluation of the returned device.Method & results: product evaluation and results: visual inspection: visual inspection was performed as part of the material analysis: "tibial baseplate with fracture.Femoral component, the tibial insert and a detached piece of the tibial baseplate.Tibial baseplate with explantation damage observed.On visual examination, the fracture was observed laterally through the baseplate.".Material analysis: a material analysis was performed and concluded the following: "review of tibial baseplate, catalogue # 180615, lot code 26201018 confirmed fracture of the baseplate.Characterisation using stereo microscopy and scanning electron microscopy confirmed fracture through the baseplate.The device fractured in fatigue and the fracture initiated at or near the location of laser marking on the baseplate.".Clinician review: a review of the provided medical information by a clinical consultant indicated: "conclusion of assessment: this inquiry reports revision of a failed unicompartmental knee arthroplasty, converted to a total knee arthroplasty due to failure of the baseplate a little over 2 years after implantation.I can confirm that this event took place since i was able to review the primary and revision operative report.Regarding the possible root cause of this event, i cannot determine it with certainty.Loosening and/or breakage of a tibial component is unusual at only 2 years but causes are multifactorial, including surgical technique factors, patient factors and less likely, implant factors.".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 a fractured tibial baseplate.A material analysis was performed on the returned device and concluded the following: "review of tibial baseplate, catalogue # 180615, lot code 26201018 confirmed fracture of the baseplate.Characterisation using stereo microscopy and scanning electron microscopy confirmed fracture through the baseplate.The device fractured in fatigue and the fracture initiated at or near the location of laser marking on the baseplate." the event was further confirmed via clinician review of the provided medical records.It is likely that patient trauma contributed to the device failure as it was reported that the patient is prone to falling.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: MCK TIBIAL BASEPLATE-RM/LL-SZ 5
• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12867644
• MDR Text Key: 281193746
• Report Number: 3005985723-2021-00198
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 00848486000783
• UDI-Public: 00848486000783
• 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: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 180615
• Device Catalogue Number: 180615
• Device Lot Number: 26201018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2019
• 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; Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male