MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL ONLAY INSERT-SZ 5-9MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 180705-2

Device Problems Degraded (1153); Material Integrity Problem (2978); Insufficient Information (3190)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 11/14/2016

Event Type  malfunction  

Manufacturer Narrative

Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

Defective tibial insert, misshaped, would not fit into tibial base plate properly.Insert would not fit due to manufacture defect surgical delay: 30 seconds to open another insert and insert into patient.

Manufacturer Narrative

An event regarding damage involving a mako trial was reported.The event was confirmed.Method & results: -device evaluation and results: the device was returned in used condition.There are scratches in various areas of the trial.There is a piece broken off from the right corner of the trial.Examination of the returned device with material analysis engineer indicated that damage observed is consistent with contact against a hard object and explantation.-medical records received and evaluation: not performed as patient factors did not contribute to the event.-device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies -complaint history review: there has been no other event for the lot referenced.Conclusions: the visual inspection and an examination by the mar team concluded that the damage observed is consistent with contact against a hard object and explantation and further assessment was not required.

Event Description

Defective tibial insert, misshaped, would not fit into tibial base plate properly.Insert would not fit due to manufacture defect surgical delay: 30 seconds to open another insert and insert into patient.

• Brand Name: MCK TIBIAL ONLAY INSERT-SZ 5-9MM
• Type of Device: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer Contact: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6366230
• MDR Text Key: 68609645
• Report Number: 3005985723-2017-00101
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 03/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 180705-2
• Device Lot Number: 12020515-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2015
• 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