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

Catalog Number	5530-G-313
Medical Device Problem Codes	Degraded (1153); Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Joint Laxity (4526); Insufficient Information (4580)
Date of Event	01/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Device evaluation is under review.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Event or Problem Description
As reported: "revision left total knee.The surgeon requested investigation results from this complaint because he said the implants have been in for less than 5 years.No information from the index surgery was provided.The knee was not revised to stryker implants so the only information i have from the doctor or hospital is the pictures provided below.The surgeon also requested that the implants be returned to stryker for the investigation." rep confirmed that a stryker patellar component was left in situ.
Additional Manufacturer Narrative
Reported event: an event regarding instability involving a triathlon insert was reported.The event was confirmed through a medical review of clinical data.Wear was identified during inspection.Method & results: -visual inspection: visual inspection of the returned device indicated evidence of wear on the articulating surface of the poly insert.Yellow discoloration is also present.Damage consistent with contact with explantation tooling, can also be seen.Dimensional inspection: dimensional inspection was not performed because the device was returned damaged.Functional inspection: functional inspection was not performed because the device was returned damaged.Material analysis: materials analysis: the yellow discoloration observed on the tibial insert is consistent with the absorption of synovial fluid by the device.-clinician review: a review of the provided medical records by a clinical consultant stated the following comment: the lateral tka x-ray shows the femoral component is significantly subluxed posteriorly in regard to the tibial component.On the ap x-ray the medial and lateral joint spaces show significant widening of the medial compartment.These findings are consistent with marked soft tissue instability and tka failure.Tka failure is confirmed.The root cause of this tka failure cannot be determined from the documentation provided.Should further documentation become available i would be happy to further this investigation.-product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient was revised.The device was returned for evaluation.Visual inspection of the returned device indicated evidence of wear on the articulating surface of the poly insert.Yellow discoloration is also present.Damage consistent with contact with explantation tooling, can also be seen.A review of the provided medical records by a clinical consultant stated the following comment: the lateral tka x-ray shows the femoral component is significantly subluxed posteriorly in regard to the tibial component.On the ap x-ray the medial and lateral joint spaces show significant widening of the medial compartment.These findings are consistent with marked soft tissue instability and tka failure.Tka failure is confirmed.The root cause of this tka failure cannot be determined from the documentation provided.The exact cause of the event could not be determined because insufficient information was provided.Further information such as operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
As reported: "revision left total knee.The surgeon requested investigation results from this complaint because he said the implants have been in for less than 5 years.No information from the index surgery was provided.The knee was not revised to stryker implants so the only information i have from the doctor or hospital is the pictures provided below.The surgeon also requested that the implants be returned to stryker for the investigation." rep confirmed that a stryker patellar component was left in situ.

• Brand Name: TRIATHLON CR 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21395107
• Report Number: 0002249697-2025-00207
• Device Sequence Number: 8274163
• Product Code: MBH
• UDI-Device Identifier: 07613327050455
• UDI-Public: 07613327050455
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2025

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: 11/30/2018
• Device Catalogue Number: 5530-G-313
• Device Lot Number: MMPMEM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2025
• Supplement Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2013
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown