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

Catalog Number 180607

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Discomfort (2330); Injury (2348)

Event Date 02/28/2018

Event Type  Injury  

Manufacturer Narrative

The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.Device not available.

Event Description

This pi is for the mako implants for the left knee.A completed medwatch form (not yet submitted to the fda) was provided by patient's attorney.That form reports "the patient had bilateral mako unicompartmental knee arthroplasty.Placed, according to operative report, it was mako size 6 femur, size 7 tibia, 8 mm polyethylene insert.Pain continued after the implant.A visit to the er on (b)(6) had him sent back to his surgeon who did an x-ray which showed bilateral fractures of the medical condyles by the base plates.The patient required extensive surgery to remove and replace the implants" additional information received: allegations: its alleged that the patient underwent bilateral mako partial knee replacements on (b)(6) 2018.Shortly after implantation, the patient began to experience pain in both knees.An er visit on (b)(6) 2018 revealed fractures by the baseplates.The patient's right knee was then revised on (b)(6) 2018 and his left knee was revised on (b)(6) 2018.

Manufacturer Narrative

Reported event.An event regarding periprosthetic fracture involving a mako baseplate was reported.The event was confirmed via medical review.Method & results.-product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: a review of the provided medical records by a clinical consultant stated the following comment: no examination of the explanted components, no operative reports of the open reduction internal fixation procedures of the tibial plateau fractures, and no follow-up subsequent to (b)(6) 2018 is available for review.In this large, obese male patient with bilateral long-standing osteoarthritis of the knees with bilateral varus deformities not corrected by bilateral medial unicompartmental knee arthroplasties, the indication for unicompartmental knee arthroplasties is questionable.The surgical pathology report of the left knee revision seven weeks after the unicompartmental knee surgery noted "knee fragments" from the other two compartments of the left knee as "consistent with osteoarthritis", which would also question the initial indication for unicompartmental knee arthroplasty in this patient.The post-operative varus position of the knees as well as the subluxation indication acl insufficiency and arthritis in the other knee compartments all resulted in excessive force generate across the medial uka which resulted in the inevitable fatigue fracture of the medial tibial plateau.This clinical situation was unlikely related to the material, design, or manufacturing of the unicompartmental components implanted in this patient.-product history review: review of the device history records indicate (b)(4) devices were manufactured and accepted into final stock on 1-may-2017 with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: a review of the provided medical records by a clinical consultant stated the following comment: no examination of the explanted components, no operative reports of the open reduction internal fixation procedures of the tibial plateau fractures, and no follow-up subsequent to august 23, 2018 is available for review.In this large, obese male patient with bilateral long-standing osteoarthritis of the knees with bilateral varus deformities not corrected by bilateral medial unicompartmental knee arthroplasties, the indication for unicompartmental knee arthroplasties is questionable.The surgical pathology report of the left knee revision seven weeks after the unicompartmental knee surgery noted "knee fragments" from the other two compartments of the left knee as "consistent with osteoarthritis", which would also question the initial indication for unicompartmental knee arthroplasty in this patient.The post-operative varus position of the knees as well as the subluxation indication acl insufficiency and arthritis in the other knee compartments all resulted in excessive force generate across the medial uka which resulted in the inevitable fatigue fracture of the medial tibial plateau.This clinical situation was unlikely related to the material, design, or manufacturing of the unicompartmental components implanted in this patient.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.Device not returned.

Event Description

This pi is for the mako implants for the left knee.A completed medwatch form (not yet submitted to the fda) was provided by patient's attorney.That form reports "the patient had bilateral mako unicompartmental knee arthroplasty.Placed, according to operative report, it was mako size 6 femur, size 7 tibia, 8 mm polyethylene insert.Pain continued after the implant.A visit to the er on february 17 had him sent back to his surgeon who did an x-ray which showed bilateral fractures of the medical condyles by the base plates.The patient required extensive surgery to remove and replace the implants".Additional information received: allegations: its alleged that the patient underwent bilateral mako partial knee replacements on (b)(6) 2018.Shortly after implantation, the patient began to experience pain in both knees.An er visit on (b)(6) 2018 revealed fractures by the baseplates.The patient's right knee was then revised on (b)(6) 2018 and his left knee was revised on (b)(6) 2018.

• Brand Name: MCK TIBIAL BASEPLATE-LM/RL-SZ 7
• Type of Device: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8209451
• MDR Text Key: 131891624
• Report Number: 3005985723-2019-00009
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• PMA/PMN Number: K090763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 07/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/09/2022
• Device Catalogue Number: 180607
• Device Lot Number: 26441016-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR