MAUDE Adverse Event Report: MAKO SURGICAL CORP. MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 2 - 8 MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 180732-1

Device Problems Dent in Material (2526); Device Operates Differently Than Expected (2913); Installation-Related Problem (2965); Scratched Material (3020); Noise, Audible (3273)

Patient Problem Injury (2348)

Event Date 06/08/2018

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the reported lot.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not returned.

Event Description

A size 2 8 mm uni onlay insert was implanted on (b)(6) 2018.The patient complained of a squeaking sound on deep flexion.During a revision of the knee surgeon explanted the insert, as it was not locked into the baseplate.The patient does cross fit training and is very active.We put in another insert.Pka case.

Event Description

A size 2 8 mm uni onlay insert was implanted on (b)(6) 2018.The patient complained of a squeaking sound on deep flexion.During a revision of the knee surgeon explanted the insert, as it was not locked into the baseplate.The patient does cross fit training and is very active.We put in another insert.Pka case.Update 07 august 2018: as per medical review received, the most obvious problem confirmed both on x-ray and in the mar is malalignment between femoral and tibial component with symptoms of metal contact between devices.The malalignment is caused by incomplete locking of the poly liner in the baseplate as reported from the revision surgery.

Manufacturer Narrative

An event regarding disassociation involving a mako insert was reported.The event was confirmed through clinician review of the medical records provided.Malalignment between femoral and tibial component was also confirmed through clinician review.Method & results: device evaluation and results: the material analysis report(mar) concluded:burnishing, scratching and third-body indentations were observed on the proximal surface of the insert.These are common damage modes of uhmwpe.Damage consistent with contact against a hard object and potentially misalignment between the insert and baseplate were also observed.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Clinician review: a review of the provided medical records revealed "incomplete seating of a poly liner in a mako pka tibial device has caused malalignment in the knee with metal-metal contact between femoral and tibial pka with squeaking sounds from the knee as adverse outcome and requiring revision".Product history review: indicated 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 lot referenced.Conclusion: an event regarding disassociation involving a mako insert was reported.The mar concluded: burnishing, scratching and third-body indentations were observed on the proximal surface of the insert.These are common damage modes of uhmwpe.Damage consistent with contact against a hard object and potentially misalignment between the insert and baseplate were also observed.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Review of the medical records provided revealed incomplete seating of a poly liner in a mako pka tibial device has caused malalignment in the knee with metal-metal contact between femoral and tibial pka with squeaking sounds from the knee as adverse outcome and requiring revision".No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 2 - 8 MM
• 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: 7659721
• MDR Text Key: 113064481
• Report Number: 3005985723-2018-00403
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 00848486016395
• UDI-Public: 00848486016395
• Combination Product (y/n): N
• PMA/PMN Number: K150307
• 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: 09/07/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 180732-1
• Device Lot Number: M830PX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2018
• Initial Date Manufacturer Received: 06/08/2018
• Initial Date FDA Received: 07/03/2018
• Supplement Dates Manufacturer Received: 08/10/2018
• Supplement Dates FDA Received: 09/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention