MAUDE Adverse Event Report: MAKO SURGICAL CORP. UNKNOWN MAKO FEMORAL COMPONENT; KNEE IMPLANT

Catalog Number UNK_JR

Device Problems Malposition of Device (2616); Noise, Audible (3273)

Patient Problem Injury (2348)

Event Date 06/08/2018

Event Type  Injury  

Manufacturer Narrative

An event regarding malposition involving a mako femoral component was reported.The event was confirmed through clinician review of the medical records provided.Method & results: product evaluation and results: not performed as the device was not returned.It remains implanted.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: not performed as no lot information was provided.Complaint history review: not performed as no lot information was provided.Conclusion: an event regarding disassociation involving a mako femoral component was reported.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.

Event Description

A size 28 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 the 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, 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.

• Brand Name: UNKNOWN MAKO FEMORAL COMPONENT
• Type of Device: KNEE IMPLANT
• 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7838401
• MDR Text Key: 119057126
• Report Number: 3005985723-2018-00518
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 08/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_JR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 48