MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL BASEPLATE-LM/RL-SZ 6; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Model Number 180606

Device Problem Fracture (1260)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Pain (1994); Insufficient Information (4580)

Event Date 01/04/2023

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 if additional information becomes available.

Event Description

It was reported a restoris left medial pka was revised due to a broken baseplate (no direct cause for breakage was reported to the rep).Patient was converted to a tka with stem and augments on the tibial side.

Event Description

It was reported a restoris left medial pka was revised due to a broken baseplate (no direct cause for breakage was reported to the rep).Patient was converted to a tka with stem and augments on the tibial side.

Manufacturer Narrative

Reported event: an event regarding crack/fracture and periprosthetic fracture involving a mako baseplate was reported.The event was confirmed via evaluation of the returned device and clinician review of the provided medical records.Method & results: -product evaluation and results: visual inspection: visual inspection of the returned device was performed as part of the material analysis: "the image depicted shows the tibial baseplate with fracture location highlighted.Also included in the image are the femoral component, the tibial insert and a detached piece of the tibial baseplate.On visual examination, the fracture was observed laterally through the baseplate.Yellow discolouration consistent with oxidation, possibly a result of synovial fluid absorption, was observed on the insert." material analysis: a material analysis was performed and indicated the following: "review of tibial baseplate, catalogue # 180606, lot code 26030121-01 confirmed fracture of the baseplate.Characterisation using stereo microscopy and scanning electron microscopy confirmed fracture through the baseplate due to a mixture of overload and fatigue.".-clinician review: a review of the provided medical information by a clinical consultant indicated: "this is a case of a patient who underwent a primary medial compartment partial knee arthroplasty who then developed within two years, a fracture of the tibial baseplate necessitating revision surgery.I can confirm that the patient sustained this fracture of the tibial baseplate since i was able to review intraoperative x-rays showing the fracture.I was also able to review the primary and revision operation notes so i can confirm that those procedures occurred.The root cause of this event cannot be determined with certainty.Causes of baseplate fracture within two years following primary surgery is unusual and multifactorial.These factors include surgical factors, such as surgical technique, knee ligament balancing and kinematics, implant positioning and fixation, as well as patient factors including activity level and bmi.Implant factors could be considered but in order to determine that the implant would have to be examined by stryker engineers.Until that occurs, i would not assign any causality to the implant itself.Addendum: based upon the additional information provided, the x-ray does show a fracture of the tibial base plate with a metallic object posterior to the knee with a fracture of the medial tibial plateau.This does not change my assessment.[.] additionally, the patient has parkinson¿s disease, which, in and of itself is a risk factor for loosening of implants.When an implant loosens preferentially on one side, or the other, fracture of the implant can occur by cyclic loading.Furthermore, the patient reports a history of multiple falls, which definitely can contribute to loosening, and certainly to fracture of the base plate.".-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 baseplate and periprosthetic tibial plateau fracture.A material analysis was performed on the returned device and indicated the following: "on visual examination, the fracture was observed laterally through the baseplate.[.] characterisation using stereo microscopy and scanning electron microscopy confirmed fracture through the baseplate due to a mixture of overload and fatigue." the reported events were also confirmed through clinician review of the provided medical records, but a root cause could not be determined from the information provided: "causes of baseplate fracture within two years following primary surgery is unusual and multifactorial.These factors include surgical factors, such as surgical technique, knee ligament balancing and kinematics, implant positioning and fixation, as well as patient factors including activity level and bmi.[.] additionally, the patient has parkinson¿s disease, which, in and of itself is a risk factor for loosening of implants.When an implant loosens preferentially on one side, or the other, fracture of the implant can occur by cyclic loading.Furthermore, the patient reports a history of multiple falls, which definitely can contribute to loosening, and certainly to fracture of the base plate." 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-LM/RL-SZ 6
• 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; centennial park, elstree; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16245566
• MDR Text Key: 308149179
• Report Number: 3005985723-2023-00013
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 00848486000721
• UDI-Public: 00848486000721
• 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
• Report Date: 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 180606
• Device Catalogue Number: 180606
• Device Lot Number: 26030121-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2021
• 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: 79 YR
• Patient Sex: Male
• Patient Weight: 98 KG