MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL ONLAY INSERT-SZ 7-9MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Model Number 180515

Device Problem Device Difficult to Setup or Prepare (1487)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/14/2020

Event Type  malfunction  

Manufacturer Narrative

As part of normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplemental report will be submitted when additional information becomes available.

Event Description

During a medial partial knee mako procedure perform by the surgeon, he could not get the polyethylene insert to lock in the tibial baseplate posteriorly.The trial baseplate and trial poly was able to fit with little difficulty during the trialing stage, however the final implant poly would not lock in to the final baseplate mechanism despite the surgeons efforts.Four different polyethylene inserts where used with the same outcome.Ultimately the surgeon made the decision to complete the case without achieving complete locking of the insert posteriorly ¿ it achieved locking anteriorly on each occasion.1h delay.Update.Tourniquet was continued to be used during the delay but was turned off at a tourniquet time of two hours.

Manufacturer Narrative

Reported event: an event regarding seating/locking issues involving a mako insert was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device and the primary operative report are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

During a medial partial knee mako procedure perform by the surgeon, he could not get the polyethylene insert to lock in the tibial baseplate posteriorly.The trial baseplate and trial poly was able to fit with little difficulty during the trialing stage, however the final implant poly would not lock in to the final baseplate mechanism despite the surgeons efforts.Four different polyethylene inserts where used with the same outcome.Ultimately the surgeon made the decision to complete the case without achieving complete locking of the insert posteriorly ¿ it achieved locking anteriorly on each occasion.1h delay: update: tourniquet was continued to be used during the delay but was turned off at a tourniquet time of two hours.

• Brand Name: MCK TIBIAL ONLAY INSERT-SZ 7-9MM
• 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: 10812270
• MDR Text Key: 216594557
• Report Number: 3005985723-2020-00348
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 00848486000646
• UDI-Public: 00848486000646
• Combination Product (y/n): N
• PMA/PMN Number: K090763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/26/2021
• Device Model Number: 180515
• Device Catalogue Number: 180707-2
• Device Lot Number: 12221016-1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other