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 Problem Insufficient Information (3190)

Patient Problems Purulent Discharge (1812); Discomfort (2330); Ambulation Difficulties (2544)

Event Date 11/23/2015

Event Type  Injury  

Manufacturer Narrative

The following other devices were also listed in this report: triathlon symmetric x3 patella; cat# 5550-g-360; lot# l175.Triathlon prim tib baseplate - cemented; cat# 5520-b-600; lot# krmka.Triathlon ps fem component, cemented; cat# 5515-f-601; lot# motva.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.An evaluation of the device cannot be performed as the device remained implanted in the patient 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

Patient called stryker stating that their knee feels loose inside and the doctor's cannot determine why the knee feels loose.When walking patient states he feels a catching sensation/sticking.Patient states their surgical site develops pustules that ooze bloody puss like substance every few weeks.No infection confirmed at this point.This is the patient's left knee.

Manufacturer Narrative

An event regarding knee instability involving a triathlon insert was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as no items associated with the event were returned or made available for evaluation.Medical records received and evaluation: not performed as no medical records were provided.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 event could not be confirmed nor the root cause 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.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.

Event Description

Patient called stryker stating that their knee feels loose inside and the doctor's cannot determine why the knee feels loose.When walking patient states he feels a catching sensation/sticking.Patient states their surgical site develops pustules that ooze bloody puss like substance every few weeks.No infection confirmed at this point.This is the patient's left knee.

• 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: 5307397
• MDR Text Key: 33792734
• Report Number: 0002249697-2015-04293
• 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: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/23/2015

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: Lay User/Patient
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: 5532-G-613
• Device Lot Number: MNMH9K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/23/2015
• Initial Date FDA Received: 12/17/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2014
• 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): Other
• Patient Age: 67 YR