MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM TIB BPLATE CEMENTED SZ 3; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer

Catalog Number	5520-B-300
Medical Device Problem Codes	Unstable (1667); Migration (4003)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Inadequate Osseointegration (2646); Osteopenia/ Osteoporosis (2651); Joint Laxity (4526); Muscle/Tendon Damage (4532)
Date of Event	02/05/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: cat#;device name; lot#: (b)(6) ;triathlon cr fem comp #4 r-cem;bt6eu.(b)(6) ;triathlon cs ins size 3 13mm;lma702.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
The following information was provided: it was reported that: patient did primary tkr on (b)(6) 2025.Came back with an unstable joint.Surgeon informed that mcl is ruptured, decided to do a revision with mrh on (b)(6) 2026.Mrh tibia baseplate couldn't cover well on the remaining surface due to the long stem.Surgeon complained about our mrh system that doesn't allow tibia offset.Patient's bone quality was found very osteoperosis and was advised by surgeon to walk with walking aid after revision surgery.

• Brand Name: TRIATHLON PRIM TIB BPLATE CEMENTED SZ 3
• Common Device Name: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer
• 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: anna ryan ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 24501321
• Report Number: 0002249697-2026-00161
• Device Sequence Number: 10510118
• Product Code: JWH
• UDI-Device Identifier: 07613327050318
• UDI-Public: 07613327050318
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 10/01/2026

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: 5520-B-300
• Device Lot Number: 42A3D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2026
• Supplement Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/06/2025
• 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: Female
• Patient Race: Asian