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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870)
Date of Event	09/06/2022
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.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.H3 other text : device not returned to the manufacturer.
Event or Problem Description
Patient had a primary left tka on (b)(6) 2022.The patient fell and had a periprosthetic fracture around the femur b2.Underwent revision for all components except the patella.Tibial baseplate was revised due to change the construct.
Event or Problem Description
Patient had a primary left tka on august 5th, 2022.The patient fell and had a periprosthetic fracture around the femur b2.Underwent revision for all components except the patella.Tibial baseplate was revised due to change the construct.
Additional Manufacturer Narrative
An event regarding periprosthetic fracture involving a triathlon femoral component was reported.The event was confirmed through medical review.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: a review of the provided medical records by a clinical consultant indicated: "this patient sustained a fall approximately one month following primary total knee arthroplasty necessitating revision to a modular rotating hinge implant due to periprosthetic fracture of the femur.I can confirm that both the primary and revision implants occurred since i was able to see x-rays and also operation reports.The root cause of this event appears apparent.The patient has an elevated bmi and sustained a fall which resulted in a periprosthetic fracture of the femur.Possibly, a contributing factor however was the fact that a very thick and constrained implant was utilized without a stem extension on the femur.Therefore a fall with a valgus or varus or rotational force could more easily cause a fracture than if a stem extension was in place.I certify that i have completed the medical risk assessment form to the best of my abilities as a health care professional and that my opinions solely reflect my personal and independent medical judgement and analysis." -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: it was reported that the patient was revised due to periprosthetic fracture of the femur.A review of the provided medical records by a clinical consultant indicated: "this patient sustained a fall approximately one month following primary total knee arthroplasty necessitating revision to a modular rotating hinge implant due to periprosthetic fracture of the femur.I can confirm that both the primary and revision implants occurred since i was able to see x-rays and also operation reports.The root cause of this event appears apparent.The patient has an elevated bmi and sustained a fall which resulted in a periprosthetic fracture of the femur.Possibly, a contributing factor however was the fact that a very thick and constrained implant was utilized without a stem extension on the femur.Therefore a fall with a valgus or varus or rotational force could more easily cause a fracture than if a stem extension was in place.I certify that i have completed the medical risk assessment form to the best of my abilities as a health care professional and that my opinions solely reflect my personal and independent medical judgement and analysis." no further investigation for this event is possible at this time.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
• 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: 17438308
• Report Number: 0002249697-2023-00866
• Device Sequence Number: 21077316
• Product Code: MBH
• UDI-Device Identifier: 07613327050387
• UDI-Public: 07613327050387
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K042993
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2023

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 Catalogue Number: 5515-F-401
• Device Lot Number: IEY7HII47V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/12/2023
• Supplement Date Received by Manufacturer: 08/22/2023
• Initial Report FDA Received Date: 08/01/2023
• Supplement Report FDA Received Date: 09/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2022
• 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: 78 YR
• Patient Sex: Female
• Patient Weight: 109 KG