MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #6 R-CEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5510F602

Device Problems Unintended Movement (3026); Insufficient Information (3190)

Patient Problems Injury (2348); Ambulation Difficulties (2544); No Code Available (3191)

Event Date 11/30/2015

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was retained by the hospital and was not returned to the manufacturer.Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.

Event Description

Unstable total knee converted knee to a posterior stabilized construct.

Manufacturer Narrative

An event regarding instability involving a triathlon femoral component was reported.The event was confirmed through operative notes.Method and results: device evaluation and results: not performed as product was not returned.Medical records received and evaluation: medical review indicated: i have seen the rather limited info for this case with triathlon femoral component and liner exchange due to instability some 3-years post implantation.The tibial component was apparently retained.What exactly has caused failure in this case, the balance between patient-related and procedure-related factors cannot be substantiated in this case due to lack of proper information.More specific radiological information including clinical examination findings and/or retrieval analysis may all help further to solve this case although this case would certainly not be associated with device-related factors.Device history review: not performed as lot information was not provided.Complaint history review: not performed as lot information was not provided.Conclusions: revision surgery took place due to instability whereby the reported cr femoral and cs insert components were replaced with ps femoral and insert components.The exact cause of the event could not be determined as insufficient information was provided.Further information such as product lot codes, device return, x-rays as well as patient history and follow-up notes are needed to complete the investigation for determining a root cause.A capa trend analysis was conducted for the reported failure mode and concluded instability may result from other factors not necessarily related to the device.No further investigation for this event is possible at this time as no devices and insufficient information were received by stryker orthopaedics.If devices and / or additional information become available, this investigation will be reopened.

Event Description

Unstable total knee converted knee to a posterior stabilized construct.

• Brand Name: TRIATHLON CR FEM COMP #6 R-CEM
• 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-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5314120
• MDR Text Key: 33994171
• Report Number: 0002249697-2015-04396
• 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: 12/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 5510F602
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 56 YR