MAUDE Adverse Event Report: MAKO SURGICAL CORP. FEMORAL TRIAL STD LM/RL SIZE 5; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 170505

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/03/2018

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 trial femoral component is damaged so don¿t engage the manual impactor tool.

Manufacturer Narrative

Corrected data: d3 - manufacturing entity.An event regarding damage involving a mako trial was reported.The event was not confirmed.Method & results: product evaluation and results: the reported device was not returned however one photograph was provided for review.The photograph shows some biological material on the device but there is no damage evident medical records received and evaluation: not performed as no medical information was received for review 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 deice return 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 Description

The trial femoral component is damaged so don¿t engage the manual impactor tool.

• Brand Name: FEMORAL TRIAL STD LM/RL SIZE 5
• Type of Device: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8045883
• MDR Text Key: 127352728
• Report Number: 3005985723-2018-00654
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 00848486003500
• UDI-Public: 00848486003500
• Combination Product (y/n): N
• PMA/PMN Number: K090763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 03/14/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 170505
• Device Lot Number: 26310912
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/10/2018
• Initial Date FDA Received: 11/07/2018
• Supplement Dates Manufacturer Received: 02/14/2019
• Supplement Dates FDA Received: 03/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other