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 Break (1069); Fitting Problem (2183); Material Deformation (2976)

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

Event Date 11/23/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The size 6x8mm poly trial insert at glastonbury surgical center became damaged during removal.Poly insert trial became damaged during removal from the joint.The plastic no longer correctly sits on baseplate due to misshapen state.

Manufacturer Narrative

An event regarding damage involving a mako trial was reported.The event was confirmed.Device evaluation and results: visual inspection of returned device indicated that device is returned in used condition and damages were observed throughout the device.Examination of device by a material analyst engineer indicated the damage is consistent with explant damage.No medical records or x-rays were made available for evaluation.Device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.There has been no other events for the lot referenced.It was reported that poly insert trial became damaged during removal from the joint.Visual inspection of returned device confirmed the event which indicated that device is returned in used condition and damages were observed throughout the device.Examination of device by a material analyst engineer indicated the damage is consistent with explant damage.If the additional information are received, this investigation will be reopened and re-evaluated.

Event Description

The size 6x8mm poly trial insert at glastonbury surgical center became damaged during removal.Poly insert trial became damaged during removal from the joint.The plastic no longer correctly sits on baseplate due to misshapen state.

• 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: timothy rice ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6153186
• MDR Text Key: 62140414
• Report Number: 3005985723-2016-00423
• 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: 12/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2016
• 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: 12420515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2015
• 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
• Patient Age: 66 YR