MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL ONLAY INSERT-SZ 7-8MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY

Model Number 180707-1

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.Device not returned.

Event Description

During a medial partial knee mako procedure performed by (b)(6), 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 7-8MM
• Type of Device: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY
• 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: alessandra chavez ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 10812277
• MDR Text Key: 215530075
• Report Number: 3005985723-2020-00351
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 00848486000974
• UDI-Public: 00848486000974
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K090763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/09/2020

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 Model Number: 180707-1
• Device Catalogue Number: 180707-1
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2020
• 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): Other