MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #4 L-CEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5510F401
Medical Device Problem Codes	Unstable (1667); Implant subsidence (4078)
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.
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 malposition & instability involving a triathlon femoral component was reported.The event was confirmed through a medical review of clinical data.Method & results: -visual inspection: visual inspection: the femoral component was returned for evaluation.On the inferior surface there is evidence of bone cement with bone in-growth on the condyles.Damage consistent with explantation observed.Dimensional inspection: dimensional inspection for the device was not performed as this aspect was not in question.Functional inspection: functional inspection for the device was not performed as this aspect was not in question.Material analysis: material analysis for the device was not performed as this aspect was not in question.-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 femoral component was returned for evaluation.On the inferior surface there is evidence of bone cement with bone in-growth on the condyles.Damage consistent with explantation observed.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.

• Brand Name: TRIATHLON CR FEM COMP #4 L-CEM
• 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-LIMERICK; raheen business park; limerick NA ; EI NA
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21399686
• Report Number: 0002249697-2025-00208
• Device Sequence Number: 18201623
• Product Code: MBH
• UDI-Device Identifier: 07613327040272
• UDI-Public: 07613327040272
• 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: 01/31/2021
• Device Catalogue Number: 5510F401
• Device Lot Number: ATN4H
• 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: 01/07/2016
• 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