MAUDE Adverse Event Report: MAKO SURGICAL CORP. FEMORAL TRIAL STD LM/RL SIZE 6; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY

Catalog Number 170506

Device Problem Device Difficult to Setup or Prepare (1487)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/13/2019

Event Type  malfunction  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

The surgeon went to remove the femoral trial after trialing and was unable to thread the femoral removal tool into the trial.He removed it using an osteotome and a mallet.Case type: pka.

Event Description

The surgeon went to remove the femoral trial after trialing and was unable to thread the femoral removal tool into the trial.He removed it using an osteotome and a mallet.Case type: pka.

Manufacturer Narrative

An event regarding thread damage involving a mako trial was reported.The event was not confirmed.Method & results: device evaluation and results: a visual, functional and dimensional inspection 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 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 1 other similar event for the reported lot.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

• Brand Name: FEMORAL TRIAL STD LM/RL SIZE 6
• Type of Device: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8417344
• MDR Text Key: 138795948
• Report Number: 3005985723-2019-00225
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 00848486003517
• UDI-Public: 00848486003517
• 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: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 170506
• Device Lot Number: 26220912
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other