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

Catalog Number	180502
Medical Device Problem Codes	Loss of Osseointegration (2408); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Arthritis (1723); Injury (2348); Inadequate Osseointegration (2646)
Date of Event	08/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: mck tibial baseplate-lm/rl-sz 2; cat# 180602; lot# 26030115-01, 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.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.
Event or Problem Description
Surgeon revised a mako uni medial left knee for disease progression to the pf joint.
Additional Manufacturer Narrative
An event regarding a revision for patients' disease progression was reported.The event was not 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 patello-femoral 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 or Problem 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 FEMORAL-LM-RL-SZ 2
• Common Device Name: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 6864782
• Report Number: 3005985723-2017-00434
• Device Sequence Number: 13640959
• Product Code: NPJ
• UDI-Device Identifier: 00848486000547
• UDI-Public: 00848486000547
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K090763
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/17/2020
• Device Catalogue Number: 180502
• Device Lot Number: 26520315-01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/16/2017
• Supplement Date Received by Manufacturer: 11/30/2017
• Initial Report FDA Received Date: 09/14/2017
• Supplement Report FDA Received Date: 12/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 61 YR