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-513
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Injury (2348); Joint Laxity (4526)
Date of Event	10/10/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device not returned.
Event or Problem Description
It was reported through the communication of an attorney that allegedly the patient was revised due to unstable right total knee.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Reported event an event regarding instability involving a triathlon insert was reported.The event was confirmed.Method & results product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Medical records received and evaluation: a review with a clinical consultant indicated "confirmation of event: based upon information provided i can confirm that the patient underwent a total knee arthroplasty on (b)(6) 2012 and underwent revision presumably for instability on (b)(6) 2013.Aiding in corroborating this are the grids which provide evidence of product usage.Root cause analysis: the root cause of this event cannot be determined information supplied.The root causes of revision for an unstable total knee arthroplasty are multifactorial including surgical technique factors, patient factors including stretching of the ligament envelope, lifestyle, activity level and bmi." -product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: a review with a clinical consultant indicated "confirmation of event: based upon information provided i can confirm that the patient underwent a total knee arthroplasty on (b)(6) 2012 and underwent revision presumably for instability on (b)(6) 2013.Aiding in corroborating this are the grids which provide evidence of product usage.Root cause analysis: the root cause of this event cannot be determined information supplied.The root causes of revision for an unstable total knee arthroplasty are multifactorial including surgical technique factors, patient factors including stretching of the ligament envelope, lifestyle, activity level and bmi.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIATHLON PS X3 TIBIAL INSERT
• Common Device Name: 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8964641
• Report Number: 0002249697-2019-03092
• Device Sequence Number: 2520616
• Product Code: MBH
• UDI-Device Identifier: 07613327050790
• UDI-Public: 07613327050790
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2017
• Device Catalogue Number: 5532-G-513
• Device Lot Number: MLP09V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2019
• Supplement Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 09/05/2019
• Supplement Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 48 YR
• Patient Sex: Unknown