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

Model Number	5510-F-401
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.H3 other text : device not returned.
Event or Problem Description
The following was reported: "revision of a cracked broken 4 left cr femur put in 2009.".
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a triathlon femoral component was reported.The event was confirmed through medial review and review of the provided photographs.Method & results: product evaluation and results: the reported device was not returned however photographs were provided for review.The photographs show a recently explanted triathlon femoral component.The device appears to be broken.Material analysis: clinician review: a review of the provided medical records by a clinical consultant indicated: undated/unlabeled: undated/unlabeled: lateral x-ray.There is a small step-off in the metal implant likely representing the metallic fracture.The implant appears well fixed.Conclusion/assessment: no significant medical history was provided for review besides the pi report and the two x-rays.The x-rays do confirm breakage of the femoral component.The etiology and reported revision could not be confirmed.Event confirmation: a fracture of the metallic femoral component was confirmed.Root cause: the root cause of the femoral component fracture cannot be determined from the information provided for review." 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.Conclusion: it was reported that the patient was revised due to a fractured femoral component.A review of the provided medical records by a clinical consultant indicated: "undated/unlabeled: lateral x-ray.There is a small step-off in the metal implant likely representing the metallic fracture.The implant appears well fixed.Conclusion/assessment: no significant medical history was provided for review besides the pi report and the two x-rays.The x-rays do confirm breakage of the femoral component.The etiology and reported revision could not be confirmed.Event confirmation: a fracture of the metallic femoral component was confirmed.Root cause: the root cause of the femoral component fracture cannot be determined from the information provided for review." the reported device was not returned however photographs were provided for review.The photographs show a recently explanted triathlon femoral component.The device appears to be broken.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
The following was reported: "revision of a cracked broken 4 left cr femur put in 2009.".

• 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: 16917161
• Report Number: 0002249697-2023-00507
• Device Sequence Number: 6921449
• Product Code: MBH
• UDI-Device Identifier: 07613327040272
• UDI-Public: 07613327040272
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2023

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: 06/30/2014
• Device Model Number: 5510-F-401
• Device Catalogue Number: 5510F401
• Device Lot Number: SMT8J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/18/2023
• Supplement Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 05/12/2023
• Supplement Report FDA Received Date: 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2009
• 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 Age: 67 YR
• Patient Sex: Female