MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PKR FEMUR NO 5 RM/LL; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	5610-F-502
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported by the customer that "revision from a uni knee to a total knee due to wear on the uni polyethylene and progression of disease - upon surgical approach noticed that the femoral component was broken".
Event or Problem Description
No new information.
Additional Manufacturer Narrative
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: visual inspection was performed as part of the material analysis report (mar).This inspection indicated 'the images depicted shows the (a) distal and (b) proximal side of the triathlon pkr baseplate, triathlon x3 insert, and triathlon pkr femoral with patterns of wear highlighted on the baseplate and insert and the fracture of the femoral component is also highlighted.' dimensional inspection: not performed because the device was returned damaged.Functional inspection: not performed because the device was returned damaged.Material analysis: a material analysis has been performed.The report concluded: 'review of the triathlon pkr baseplate, catalogue # 5620-b-502, lot code ashka, triathlon pkr insert x3, catalogue # 5630-g-528, lot code mjm3tt, and triathlon pkr femoral, catalogue # 5610-f 502 confirmed wear on the x3 insert and baseplate, as well as fracture of the pkr femoral.Characterisation using visual, stereo microscope, and secondary electron imaging confirmed fracture of the pkr femoral in fatigue with final fracture in overload.No manufacturing or material related defects were observed on the examined areas of the components.' clinician review: no medical records were received for review with a clinical consultant product history review: a review of the device history records could not be performed as lot code information was unknown.Complaint history review: could not be performed as lot code information was not provided.Conclusions: it was reported by the customer that "revision from a uni knee to a total knee due to wear on the uni polyethylene and progression of disease - upon surgical approach noticed that the femoral component was broken".The event was confirmed via mar.Visual inspection was performed as part of the material analysis report (mar).This inspection indicated 'the images shows the (a) distal and (b) proximal side of the triathlon pkr baseplate, triathlon x3 insert, and triathlon pkr femoral with patterns of wear highlighted on the baseplate and insert and the fracture of the femoral component is also highlighted.' a material analysis has been performed.The report concluded: 'review of the triathlon pkr baseplate, catalogue # 5620-b-502, lot code ashka, triathlon pkr insert x3, catalogue # 5630-g-528, lot code mjm3tt, and triathlon pkr femoral, catalogue # 5610-f 502 confirmed wear on the x3 insert and baseplate, as well as fracture of the pkr femoral.Characterisation using visual, stereo microscope, and secondary electron imaging confirmed fracture of the pkr femoral in fatigue with final fracture in overload.No manufacturing or material related defects were observed on the examined areas of the components.' 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 PKR FEMUR NO 5 RM/LL
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21323340
• Report Number: 0002249697-2025-00170
• Device Sequence Number: 8128192
• Product Code: HRY
• UDI-Device Identifier: 07613327027815
• UDI-Public: 07613327027815
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K082567
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2025

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 Catalogue Number: 5610-F-502
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/14/2025
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown