MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5530-G-513

Device Problem Insufficient Information (3190)

Patient Problems Arthritis (1723); Injury (2348)

Event Date 04/24/2017

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate (b)(4) devices were manufactured and accepted into final stock on 19-jan-2009 with no reported discrepancies.Lot id: there have been no other similar events for the lot referenced.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Hospital retained.

Event Description

Sales rep reported a revision of a primary left knee due to prior osteoarthritis of patient.Surgeon took out patella & insert.

Manufacturer Narrative

An event regarding revision due to osteoarthritis involving a triathlon insert was reported.The event was not confirmed.Device evaluation and results: device was not returned however, provided explanted images of the device shows wear/damage to the insert.Medical records received and evaluation: the provided medical records were deemed insufficient and rejected for medical review.Need operative reports and reason for revision to investigate this event further.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: it was reported that patient was revised due to prior osteoarthritis of patient.The event could not be confirmed nor the root cause could be determined because the devices were not returned for evaluation and insufficient medical information was provided.Provided explanted images of the device shows wear/damage to the insert.Further information such as return of device, patient history, histopathology report & follow-up notes are needed to investigate this event further.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.

Event Description

Sales rep reported a revision of a primary left knee due to prior osteoarthritis of patient.Surgeon took out patella & insert.

• Brand Name: TRIATHLON CR X3 TIBIAL INSERT
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• 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: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6586263
• MDR Text Key: 75814841
• Report Number: 0002249697-2017-01617
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/18/2014
• Device Catalogue Number: 5530-G-513
• Device Lot Number: METL3M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2009
• 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
• Patient Age: 66 YR
• Patient Weight: 143