MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A CR BEADED #6R; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5517F602
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	07/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Event or Problem Description
Patient presented with patella tracking issues.Doctor revised the femur and changed to a ps construct.
Event or Problem Description
Patient presented with patella tracking issues.Doctor revised the femur and changed to a ps construct.
Additional Manufacturer Narrative
An event regarding malposition involving a triathlon femoral component was reported.The event was not confirmed.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 provided medical records with a clinical consultant indicated: "i have reviewed the documentation provided for the product inquiry summary and an ap and lateral tka x-ray.Event description: patient presented with patella tracking issues.Dr.(b)(6) revised the femur and changed to a ps construct.The ap and lateral x-rays show a pressfit tka in anatomic position without evidence of mechanical complication.Mal tracking patella and subsequent revision cannot be confirmed from the documentation provided.A sunrise view knee x-ray would demonstrate proper or improper patella tracking.Unfortunately this was not available.Should further documentation become available i would be happy to further this investigation." -product history review: a review of the device history records could not be performed as lot code information was unknown.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.A review of provided medical records with a clinical consultant indicated: "i have reviewed the documentation provided for the product inquiry summary and an ap and lateral tka x-ray.Event description: patient presented with patella tracking issues.Dr.Klibanoff revised the femur and changed to a ps construct.The ap and lateral x-rays show a pressfit tka in anatomic position without evidence of mechanical complication.Mal tracking patella and subsequent revision cannot be confirmed from the documentation provided.A sunrise view knee x-ray would demonstrate proper or improper patella tracking.Unfortunately this was not available.Should further documentation become available i would be happy to further this investigation."further information such as return of the device, pathology reports, pre- and post-operative x-rays and the revision operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.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 P/A CR BEADED #6R
• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19983142
• Report Number: 0002249697-2024-01121
• Device Sequence Number: 8234233
• Product Code: MBH
• UDI-Device Identifier: 07613327040999
• UDI-Public: 07613327040999
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K200782
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2024

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: 5517F602
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/22/2024
• Supplement Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 79 YR
• Patient Sex: Male