MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL BASEPLATE-LM/RL-SZ 2; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 180602

Device Problems Migration or Expulsion of Device (1395); Loss of Osseointegration (2408)

Patient Problems Injury (2348); Joint Disorder (2373); Inadequate Osseointegration (2646)

Event Date 08/16/2017

Event Type  Injury  

Manufacturer Narrative

An event regarding "progression of arthritis, loosening and subsidence" involving a mako baseplate was reported.The event was confirmed.Method & results: device evaluation and results: a visual, functional and dimensional inspection could not be performed as the device was not returned.Medical records received and evaluation: the provided medical information was submitted to a consulting clinician who indicated: "x-ray printouts available for review include a series dated (b)(6) 2015, which is an ap of both knees and lateral of the left knee, demonstrating bilateral cemented medial uka with the left knee noted on the tibial component to be loose and subsided anteriorly, and patellofemoral arthritic changes are noted.No clinical or past medical history, no patient demographics, and no examination of explanted components are available.The commonest cause of revision of a unicompartmental knee to a total knee arthroplasty is progression of arthritis to the other knee compartments.The second commonest cause is loosening or subsidence of the uka components.Both appear relevant to this case.There is no evidence of factors of faulty component design, manufacturing or materials having contributed to this clinical situation." device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there has been no other event for the lot referenced.Conclusions: the reported event was confirmed as per provided medical records reviewed by consulting clinician who indicated that tibial component to be loose and subsided anteriorly in the left knee.He further indicated that the commonest cause of revision of a unicompartmental knee to a total knee arthroplasty is progression of arthritis to the other knee compartments while the second commonest cause is loosening or subsidence of the uka components and both appear relevant to this case as there is no evidence of factors of faulty component design, manufacturing or materials having contributed to this clinical situation.Further information such as patient demographics, clinical or past medical history and examination of explanted components are needed to determine the root cause.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.Device not available.

Event Description

Surgeon revised a mako uni medial left knee for disease progression to the pf joint.Update 28-sep-2017: ".The tibial component to be loose and subsided anteriorly.The commonest cause of revision of a unicompartmental knee to a total knee arthroplasty is progression of arthritis to the other knee compartments.The second commonest cause is loosening or subsidence of the uka components.Both appear relevant to this case.".

Manufacturer Narrative

The following devices were also listed in this report: mck tibial onlay insert-sz 2-9mm; cat# 180702-2; lot# 12150615-1.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.An event regarding "progression of arthritis, loosening and subsidence" involving a mako baseplate was reported.The event was confirmed.A visual, functional and dimensional inspection could not be performed as the device was not returned.The provided medical information was submitted to a consulting clinician who indicated: "x-ray printouts available for review include a series dated (b)(6) 2015, which is an ap of both knees and lateral of the left knee, demonstrating bilateral cemented medial uka with the left knee noted on the tibial component to be loose and subsided anteriorly, and patellofemoral arthritic changes are noted.No clinical or past medical history, no patient demographics, and no examination of explanted components are available.The commonest cause of revision of a unicompartmental knee to a total knee arthroplasty is progression of arthritis to the other knee compartments.The second commonest cause is loosening or subsidence of the uka components.Both appear relevant to this case.There is no evidence of factors of faulty component design, manufacturing or materials having contributed to this clinical situation." device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.There has been no other event for the lot referenced.The reported event was confirmed as per provided medical records reviewed by consulting clinician who indicated that tibial component to be loose and subsided anteriorly in the left knee.He further indicated that the commonest cause of revision of a unicompartmental knee to a total knee arthroplasty is progression of arthritis to the other knee compartments while the second commonest cause is loosening or subsidence of the uka components and both appear relevant to this case as there is no evidence of factors of faulty component design, manufacturing or materials having contributed to this clinical situation.Further information such as patient demographics, clinical or past medical history and examination of explanted components are needed to determine the root cause.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.

Event Description

Surgeon revised a mako uni medial left knee for disease progression to the pf joint.Update 28-sep-2017: "the tibial component to be loose and subsided anteriorly.The commonest cause of revision of a unicompartmental knee to a total knee arthroplasty is progression of arthritis to the other knee compartments.The second commonest cause is loosening or subsidence of the uka components.Both appear relevant to this case.".

• Brand Name: MCK TIBIAL BASEPLATE-LM/RL-SZ 2
• Type of Device: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer Contact: timothy rice ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7069224
• MDR Text Key: 93287117
• Report Number: 3005985723-2017-00583
• Device Sequence Number: 1
• Product Code: NPJ
• 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,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/26/2020
• Device Catalogue Number: 180602
• Device Lot Number: 26030115-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2015
• 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: 61 YR