MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 5. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5537-G-509

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 07/07/2015

Event Type  Injury  

Manufacturer Narrative

The following other devices were also listed in this report: triathlon ps fem component, cemented; cat# 5515-f-602; lot# ehnyt.Tri ts baseplate size 5; cat# 5521-b-500; lot# hoit.Triathlon asym patella a35x10; cat# 5551l350; lot# lds064.It cannot be determined which, if any of these devices may have caused or contributed to the patient's infection.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.Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

Patient underwent a liner exchange with i&d wash-out.

Manufacturer Narrative

An event regarding an unspecified involving a triathlon insert was reported.The event was not confirmed.Method & results: device evaluation: not performed as the subject device was not returned.Medical records received and evaluation: not performed as no medical records were provided for review.Device history review: dhr review for the reported lot determined that the device was manufactured and packed to specification.Complaint history review: complaint history review confirmed that there have been no other similar events for the reported lot.Conclusions: the exact cause of the event could not be determined based on the information provided.Further information such as the reason why the revision surgery took place, product return, pre- and post-operative x-rays, operative reports as well as patient history and follow-up notes are needed to complete the investigation for determining a root cause.No further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Patient underwent a liner exchange with i&d wash-out.

• Brand Name: NO 5. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 9MM
• 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 navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5316265
• MDR Text Key: 34047871
• Report Number: 0002249697-2015-04449
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/08/2015

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: 06/30/2018
• Device Catalogue Number: 5537-G-509
• Device Lot Number: MMK80X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2015
• Initial Date FDA Received: 12/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2013
• 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: 74 YR
• Patient Weight: 82