MAUDE Adverse Event Report: MAKO SURGICAL CORP. TIBIAL INSERT ONLAY TRIAL-SIZE 6-8MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 170706-1

Device Problems Material Deformation (2976); Scratched Material (3020); Insufficient Information (3190)

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

Event Date 12/29/2016

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted if additional information becomes available.

Event Description

The doctor asked for a replacement because it was starting to chip apart.He noticed it while taking out the trial and wants it replaced.

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 were scratches in various areas of the trial.On the left side of the trial by the holes there were gouges.Examination of the returned device with material analysis engineer indicated that damages observed on the insert are consistent with in-service use and contact with the baseplate and explanation of the device.-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 damages observed on the insert consistent with in-service use and contact with the baseplate due to explantation and further assessment was not required.

Event Description

The doctor asked for a replacement because it was starting to chip apart.He noticed it while taking out the trial and wants it replaced.

• Brand Name: TIBIAL INSERT ONLAY TRIAL-SIZE 6-8MM
• 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6269729
• MDR Text Key: 65569143
• Report Number: 3005985723-2017-00032
• 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: 03/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 170706-1
• Device Lot Number: 12100613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other