MAUDE Adverse Event Report: MAKO SURGICAL CORP. TIBIAL INSERT ONLAY TRIAL-SIZE 4-8MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 170704-1

Device Problems Material Deformation (2976); 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 01/03/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that parts of poly insert were chipping off.

Manufacturer Narrative

An event regarding damage involving an mako tibial insert was reported.The event was confirmed.Method and results: device evaluation and results: visual inspection of returned device has been done and device found damaged.Examination of the returned device with material analysis engineer indicated damage observed are explantation damage.Medical records received and evaluation: no medical records or x-rays were made available for evaluation.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 confirms the event as the returned product was found damaged.Moreover the examination of the returned device with material analysis engineer indicated damage observed are explantation damage.No further investigation is possible at this time.If additional information is received, this investigation will be reopened and re-evaluated.

Event Description

It was reported that parts of poly insert were chipping off.

• Brand Name: TIBIAL INSERT ONLAY TRIAL-SIZE 4-8MM
• 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: 6269783
• MDR Text Key: 65527784
• Report Number: 3005985723-2017-00033
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/25/2017

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: 170704-1
• Device Lot Number: 12021115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2015
• 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