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

Catalog Number 180614

Device Problems Material Discolored (1170); Loss of Osseointegration (2408); Material Deformation (2976)

Patient Problems Pain (1994); Injury (2348); Inadequate Osseointegration (2646)

Event Date 07/31/2017

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

Patient saw physician at follow up appointment.Complained of pain, x-ray showed loosening.Revision surgery booked for right knee.

Manufacturer Narrative

An event regarding pain & loosening involving an mako baseplate was reported.The event was confirmed.Visual inspection of returned device has been done and damage is observed on returned device.Biological fixation obseved on distal surface of device.Discoloration also observed on proximal surface.The provided medical information was submitted to a consulting clinician who deemed " the xrays provided for review are undated but presumably are pre-revision as they show a medial unicompartmental arthroplasty with a tibial component that appears to have subsided and loosened.On the lateral view lucent lines exist along the cement bone interface consistent with loosening.The posterior aspect of the component appears to be lifted away from the underlying tibia with the anterior portion seated within the bone.These finding correlate with the intra-operative description of findings.The primary harm involved is early failure of fixation mako unicompartmental knee tibial component.It would be helpful to review serial radiograph no defect in the implant or manufacture was identified." 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.It was reported that patient alleged of pain and loosening.Material analysis report indicated that damage observed consistent with the explantation process.Biological fixation observed on distal surface of device.Discoloration also observed on proximal surface.As per medical review it was confirmed that in x ray, on the lateral view lucent lines exist along the cement bone interface consistent with loosening.The posterior aspect of the component appears to be lifted away from the underlying tibia with the anterior portion seated within the bone.These finding correlate with the intra-operative description of findings.The primary harm involved is early failure of fixation mako unicompartmental knee tibial component.It would be helpful to review serial radiograph no defect in the implant or manufacture was identified.If additional information are received, this investigation will be reopened and re-evaluated.

Event Description

Patient saw physician at follow up appointment.Complained of pain, x-ray showed loosening.Revision surgery booked for right knee.

• Brand Name: MCK TIBIAL BASEPLATE-RM/LL-SZ 4
• 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: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6850016
• MDR Text Key: 85271215
• Report Number: 3005985723-2017-00431
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 11/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/17/2020
• Device Catalogue Number: 180614
• Device Lot Number: 26420115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2015
• 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: 54 YR
• Patient Weight: 84