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

Catalog Number 180605

Device Problem Osseointegration Problem (3003)

Patient Problems Injury (2348); Inadequate Osseointegration (2646)

Event Date 07/01/2019

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device not available.

Event Description

Mako uni revised for aseptic loosening of tibial component.Revised to tka.

Event Description

Mako uni revised for aseptic loosening of tibial component.Revised to tka.

Manufacturer Narrative

An event regarding subsidence involving a mako baseplate was reported.The event was confirmed through review of medical records by a clinical consultant.Method & results: -device evaluation and results: visual inspection: visual inspection was performed as part of the material analysis report (mar), dated 10 sept 2019.This inspection indicated: damage consistent with the explantation process was observed on the proximal surface of tibial baseplate.Biological material was observed on the distal surface of the baseplate.Dimensional & functional inspection; the device was returned damaged and in its current condition would not be an accurate reflection of its original manufactured condition.Material analysis: a material analysis has been performed.The report concluded: explantation damage and biological material were observed on the tibial baseplate and femoral component.The tibial insert was observed to have explantation damage and back side impression markings.Burnishing, scratching, and third body indentations were observed on the articulating surface of the insert; these are common damage modes of uhmwpe.Based on the given information, no identifiable material or manufacturing discrepancies were observed on the surfaces examined.-clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: regarding the referenced pis, this case represents a male patient whose date of birth is listed as july 31, 1956.The event description states, ¿mako uni revised for aseptic loosening of tibial component.Revised to tka.¿ the date of the implant is listed as (b)(6) 2018 and the date of explant is listed as (b)(6) 2019.No operative reports are available but the listed components for the uni are an mck tibial baseplate lm/rl size.5, mck femoral lm/rl size.4, and mck tibial onlay insert size 5/8mm.It was implanted using a 3.0 rio robotic arm-mics.X-ray printouts available for review include a series dated october 23, 2018, which is an ap and lateral of the left knee, demonstrating a cemented left medial unicompartmental knee arthroplasty, reduced and in nominal position.The host bone appears osteoporotic.X-rays dated (b)(6) 2019 are two ap¿s and one lateral of the left knee demonstrating the tibial component subsided into osteoporotic bone of the tibial plateau.No clinical or past medical history, no operative reports, no patient demographics and no examination of explanted components are available.Initial post-operative x-rays demonstrate a nominally placed left medial unicompartmental knee arthroplasty into osteoporotic bone.Six months later x-rays demonstrate subsidence of the tibial component into the porotic tibial plateau.There is no evidence either the components or the robotic device were responsible for this clinical event.-device history review: all 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 reported lot.Conclusion: the investigation concluded that 'x-rays demonstrate subsidence of the tibial component into the porotic tibial plateau'.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be re-opened.

• Brand Name: MCK TIBIAL BASEPLATE-LM/RL-SZ 5
• Type of Device: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8836503
• MDR Text Key: 152494213
• Report Number: 3005985723-2019-00537
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 00848486000714
• UDI-Public: 00848486000714
• Combination Product (y/n): N
• PMA/PMN Number: K090763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 180605
• Device Lot Number: 26110417-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2019
• Date Manufacturer Received: 09/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR