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
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3005985723-2020-00348
• Device Sequence Number: 4011302
• Product Code: NPJ
• UDI-Device Identifier: 00848486000646
• UDI-Public: 00848486000646
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K090763
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 10/14/2020
• Supplement Date Received by Manufacturer: 11/12/2020
• Initial Report FDA Received Date: 11/09/2020
• Supplement Report FDA Received Date: 12/08/2020
• 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: Other