MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A CR BEADED #7R; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/META

Catalog Number	5517F702
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Inadequate Osseointegration (2646)
Date of Event	01/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was provided: surgeon did revision of right stryker pressfit cr femur and baseplate after 1 year out of surgery - surgeon did not perform the primary surgery just the revision and wants to send back femoral component.He believes not enough bone growth was on the femur.As reported by hospital management: i included the tibia so you can see there is bone growth.The femur has some too.The patient is a year or so out.The surgeon felt it did not have enough bone growth on the femur.
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

• Brand Name: TRIATHLON P/A CR BEADED #7R
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/META
• 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: 24363026
• Report Number: 0002249697-2026-00101
• Device Sequence Number: 21280773
• Product Code: JWH
• UDI-Device Identifier: 07613327041019
• UDI-Public: 07613327041019
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K242831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/17/2026

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: 5517F702
• Device Lot Number: TX24R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/16/2024
• 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 Sex: Unknown