MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 2. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 31MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5537-G-231

Device Problems Device Operates Differently Than Expected (2913); Insufficient Information (3190)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 11/12/2015

Event Type  Injury  

Manufacturer Narrative

This event was reported via clinical outcomes reporting studies.An evaluation of the device cannot be performed as the device was not made available to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

Postoperative diagnosis: patient had primary tka (b)(6) 2013.Underwent a poly liner exchange on (b)(6) 2014 and a knee revision on (b)(6) 2015 for failed tka secondary to instability and hyperextension with use of cones.

Manufacturer Narrative

Reported event: an event regarding instability involving a triathlon 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 exact cause of the reported instability could not be determined because the devices were not returned for evaluation and insufficient medical information was provided.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/or insufficient information was received by stryker orthopaedics.If devices and/or additional information become available, this investigation will be reopened.Product surveillance will continue to monitor for trends.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.

Event Description

Postopertive diagnosis: patient had primary tka (b)(6) 2013.Underwent a poly liner exchange on (b)(6) 2014 and a knee revision on (b)(6) 2015 for failed tka secondary to instability and hyperextension with use of cones.

• Brand Name: NO 2. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 31MM
• 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: sandra spokane ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5548787
• MDR Text Key: 41920915
• Report Number: 0002249697-2016-01095
• 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: 03/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2015
• Device Catalogue Number: 5537-G-231
• Device Lot Number: MJMLRP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2016
• Initial Date FDA Received: 04/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2010
• 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: 59 YR
• Patient Weight: 122