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

Catalog Number 180614

Device Problems Unintended Movement (3026); Migration (4003)

Patient Problems Subluxation (4525); Insufficient Information (4580)

Event Date 10/10/2023

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 when additional information becomes available.H3 other text : device not returned.

Event Description

Planned revision surgery.Patient presented at 2 year follow up appointment with x-ray showing the uni tibial baseplate had subsided.During the revision surgery from a medial uni to total knee the tibial and femoral components appeared to be we well fixated to bone.They were removed with minimal or no bone loss and a primary triathlon knee was implanted.

Manufacturer Narrative

Reported event: an event regarding subsidence involving a mako baseplate was reported.The event was not confirmed.Method & results: -product evaluation and results: the reported device was not returned; however, photographs were provided for review.The photographs show a femoral component, tibial baseplate, and insert that have been recently explanted and are covered in blood.There appears to be some cement adhered to the bone-interfacing sides of the devices.Explantation damage is visible on the insert as well as yellow discoloration consistent with absorption of synovial fluid.-clinician review: a review of the provided medical information by a clinical consultant indicated: "this case concerns a patient who underwent a primary medial unicompartmental knee arthroplasty then developed what the surgeon felt to be subsidence of the tibial component.At revision surgery tibia and femoral components were well fixed.A revision was carried out.I can confirm that the patient had the primary procedure since i was able to see an x-ray showing the unicompartmental knee arthroplasty.I cannot confirm the revision since i have no documentation except the date of explant with no operation report, office notes or post revision x-rays.Causes of subsidence with subsequent need for revision surgery are multifactorial including initial surgical technique, ligament balancing, restoration of kinematics, alignment and positioning as well as cement technique.Also factors include the patient's activity level and bmi.With the information provided i would not assign any causality to the implant itself." -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 subsidence of the tibial baseplate.Clinician review of the provided medical records was unable to confirm the event.Further information such as pathology reports, additional pre- and post-operative x-rays and the revision 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 devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Planned revision surgery.Patient presented at 2 year follow up appointment with x-ray showing the uni tibial baseplate had subsided.During the revision surgery from a medial uni to total knee the tibial and femoral components appeared to be we well fixated to bone.They were removed with minimal or no bone loss and a primary triathlon knee was implanted.

• Brand Name: MCK TIBIAL BASEPLATE-RM/LL-SZ 4
• Type of Device: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY
• 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: 18070532
• MDR Text Key: 327356033
• Report Number: 3005985723-2023-00168
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K082172
• 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: 02/19/2024

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 Catalogue Number: 180614
• Device Lot Number: 26040619-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2023
• Initial Date FDA Received: 11/04/2023
• Supplement Dates Manufacturer Received: 01/25/2024
• Supplement Dates FDA Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2019
• 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): Required Intervention; Hospitalization
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 76 KG