MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS FEM COMP #2L-CEM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	5515F201
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994); Injury (2348)
Date of Event	07/03/2019
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 reported discrepancies.There have been no other events for the lot referenced.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 sales representative that patient was operated on (b)(6) 2019 using tka triathlon cemented procedure.Patient experienced pain after the operation and the doctor performed an x-ray.The x-ray results revealed a distal femoral fracture, which was corrected by revision surgery on (b)(6) 2019, the revision surgery was completed successfully.
Event or Problem Description
It was reported by sales representative that patient was operated on (b)(6) 2019 using tka triathlon cemented procedure.Patient experienced pain after the operation and the doctor performed an x- ray.The x-ray results revealed a distal femoral fracture, which was corrected by revision surgery on (b)(6) 2019 , the revision surgery was completed successfully.
Additional Manufacturer Narrative
An event regarding periprosthetic fracture involving a triathlon femoral component was reported.The event was confirmed through clinician review of the provided medical records.Method & results: device evaluation and results: the reported device was not returned however photographs were provided for review.The photographs show a recently explanted triathlon femoral component with significant bone material adhered to the device.There is nothing else remarkable to note from the photo.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: x-ray confirms periprosthetic femoral fracture, need additional information; primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components.Device history review: indicated all 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: the event of peiprosthetic fracture was confirmed through clinician review of the provided medical records, however the exact cause of the event could not be determined based on the information provided.Further information such as primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components are required to determine a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIATHLON PS FEM COMP #2L-CEM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8837165
• Report Number: 0002249697-2019-02710
• Device Sequence Number: 11409750
• Product Code: JWH
• UDI-Device Identifier: 07613327040708
• UDI-Public: 07613327040708
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2019

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: 03/27/2023
• Device Catalogue Number: 5515F201
• Device Lot Number: DJ23P
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/03/2019
• Supplement Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 07/29/2019
• Supplement Report FDA Received Date: 09/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 73 YR