MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 5 - 9 MM; KNEE IMPLANT

Catalog Number 180735-2

Device Problems Off-Label Use (1494); Insufficient Information (3190)

Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Date 11/29/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A size 5x9mm onlay tibial insert was inserted on a size 6 tibial base plate.Update as per sales response received on 09-dec-2016: "reason for revision was: surgeon put a 5x9 poly on a size 6 tibia base plate.It was not product error.The 5x9mm was removed and a 6x9mm was put in place.".

Manufacturer Narrative

Corrected data: manufacturing entity and manufacturing site for devices is stryker orthopaedics-(b)(4).An event regarding incorrect selection involving a mako insert 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 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 cause of the revision in this case was likely due to the incorrect insert selection.However, further information such as return of device, operative reports, patient history & follow-up notes are needed to investigate this event further.If additional information and/or device become available, this investigation will be reopened.

Event Description

A size 5x9mm onlay tibial insert was inserted on a size 6 tibial base plate.Update as per sales response received on 09-dec-2016: "reason for revision was: surgeon put a 5x9 poly on a size 6 tibia base plate.It was not product error.The 5x9mm was removed and a 6x9mm was put in place.".

• Brand Name: MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 5 - 9 MM
• Type of Device: KNEE IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6178905
• MDR Text Key: 62539398
• Report Number: 3005738134-2016-00010
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150307
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 02/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 180735-2
• Device Lot Number: V63HXL
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/26/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention