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

Catalog Number 5532-G-613

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

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

Event Date 10/07/2016

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.

Event Description

Revision total knee.Poly swap for a previous primary total knee.Replaced with a thicker poly went from 13mm ps insert to 16mm ts insert.

Manufacturer Narrative

An event regarding revision 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: during this surgery, 13mm ps insert was revised to a 16mm ts insert for unspecified reasons.The exact root cause could not be determined because insufficient medical information was provided.Further information such as product return, x-rays including early post-operative x-rays, operative notes, patient history and follow-up notes are needed to complete the investigation for determining a root cause.No further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics.If additional information becomes available, this investigation will be reopened.

Event Description

Revision total knee.Poly swap for a previous primary total knee.Replaced with a thicker poly went from 13mm ps insert to 16mm ts insert.

• Brand Name: TRIATHLON PS 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6080089
• MDR Text Key: 59198501
• Report Number: 0002249697-2016-03466
• 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: 01/20/2017

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: 08/30/2020
• Device Catalogue Number: 5532-G-613
• Device Lot Number: K144MX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2016
• Initial Date FDA Received: 11/04/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2015
• 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): Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Weight: 79