MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #3 L-CEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5510F301
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Joint Laxity (4526); Insufficient Information (4580)
Date of Event	04/01/2025
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: "please find attached pictures of a left total knee implant that was revised (b)(6).It was reported by the surgeon that the primary surgery was bilateral total knees.The left and right knees are both unstable and the plan is to revise the right knee as well at some point.The revision was secondary to instability of the joint and evidence of loosening on bone scan and x-ray.An incision was made and when the knee was flexed it was discovered that the femoral implant was broken.The joint was revised to a competitor revision prosthesis.These implants have been retained and i will be shipping them to stryker.Please send return information and i will return as soon as they are decontaminated.No further information is available from the surgeon or hospital." rep confirmed that he and the surgeon request investigation results.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a triathlon femoral component was reported.The event was confirmed via mar.Method & results: -product evaluation and results: visual inspection was performed as part of the material analysis report (mar), dated july 15, 2025.The images shows distal and proximal side of the tibial baseplate, triathlon x3 insert, and triathlon femoral with fracture of the femoral component highlighted with an arrow.Slight yellow discolouration consistent with oxidation, possibly a result of synovial fluid absorption, was observed on the insert.Material analysis: a material analysis has been performed.The report concluded: review of the returned devices confirmed fracture of the femoral.Characterisation using visual, stereo microscope, and secondary electron imaging confirmed fracture of the femoral in fatigue with final fracture in overload.Evidence of shrinkage was found in an area of the fracture surface, however, the shrinkage was not in close proximity to the fracture origin.-clinician review: no medical records were received for review with a clinical consultant.-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: a material analysis has been performed.The report concluded: review of the returned devices confirmed fracture of the femoral.Characterisation using visual, stereo microscope, and secondary electron imaging confirmed fracture of the femoral in fatigue with final fracture in overload.Evidence of shrinkage was found in an area of the fracture surface, however, the shrinkage was not in close proximity to the fracture origin.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
No new information.

• Brand Name: TRIATHLON CR FEM COMP #3 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21914230
• Report Number: 0002249697-2025-00439
• Device Sequence Number: 7135895
• Product Code: MBH
• UDI-Device Identifier: 07613327040258
• UDI-Public: 07613327040258
• 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 Implanted Year: 2018
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2025

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: 04/30/2023
• Device Catalogue Number: 5510F301
• Device Lot Number: DT93J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/27/2018
• 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: 55 YR
• Patient Sex: Female