MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS FEM COMPONENT, CEMENTED; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5515-F-401
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Injury (2348)
Date of Event	08/29/2019
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 relevant reported discrepancies.There have been no other similar events for the lot referenced.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.
Event or Problem Description
Patient fell recently and had distal femur fracture from original surgery date of (b)(6) 2018.Today's surgery is to remove originally placed left total knee and revise to gmrs distal femoral replacement.
Event or Problem Description
Patient fell recently and had distal femur fracture from original surgery date of (b)(6) 2018.Today's surgery is to remove originally placed left total knee and revise to gmrs distal femoral replacement.
Additional Manufacturer Narrative
An event regarding periprosthetic fracture involving a triathlon femoral component reported.The event was confirmed by medical review.Method & result: - product evaluation results: visual, dimensional, functional and material analysis not performed as the product is not returned.- clinician review: the available medical records were provided to a consulting clinician for a review which was rejected stating - "x-ray provided confirms fracture, need additional information; primary and revision operative reports, clinical and past medical history." - product history review: review of the product history records indicate all devices were manufactured and accepted into final stock with no reported relevant discrepancies.- complaint history review: there have been no other events for the lot referenced.Conclusions: it was reported that patient fell recently and had distal femur fracture.The available medical records were provided to a consulting clinician for a review which was rejected stating that x-ray provided confirms fracture, need additional information; primary and revision operative reports, clinical and past medical history.The exact cause of the event could not be determined because insufficient information was received.No further investigation for this event is possible at this time as no devices and / or insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIATHLON PS FEM COMPONENT, CEMENTED
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9123618
• Report Number: 0002249697-2019-03329
• Device Sequence Number: 11346198
• Product Code: MBH
• UDI-Device Identifier: 07613327050387
• UDI-Public: 07613327050387
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2019

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: 02/28/2023
• Device Catalogue Number: 5515-F-401
• Device Lot Number: BGZ4GA
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/29/2019
• Supplement Date Received by Manufacturer: 10/16/2019
• Initial Report FDA Received Date: 09/26/2019
• Supplement Report FDA Received Date: 11/13/2019
• 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: 84 YR