MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON HINGE INSERT SIZE 6 11MM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	5612-P-611
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was provided: revised a right knee distal femoral replacement due to infection.Revised to a spacer using two retrograde nails and a plate.
Additional Manufacturer Narrative
The following devices were also listed in this report: gmrs small axle; cat#: 64952115; lot#: ctd176425.Mrhk bumper insert - neutral; cat#: 64812130; lot#: lnx427.Tri hinge tib bearing sz 1-2; cat#: 56120001; lot#: a09596a.Gmrs small femoral bushing; cat#: 64952105; lot#: lny070.Gmrs small femoral bushing; cat#: 64952105; lot#: lny054.D-m 2.0mm beaded cable set vit; cat#: 6704-0-520; lot#: 33436551.Triathlon cemented stem-15mm x 100mm; cat#: 5560-s-215; lot#: 1214755l.Gmrs dist fem comp sml r 65mm; cat#: 64952020; lot#: 2cr7d.Gmrs extension piece 30mm; cat#: 64956030; lot#: 762pu.Mrs cvd fem st w/o body 17x127; cat#: 64853817; lot#: 243799b.Triathlon hinge b/plate size 6; cat#: 5612b600; lot#: trn4l.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There has been similar event(s) 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 HINGE INSERT SIZE 6 11MM
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 25147110
• Report Number: 0002249697-2026-00397
• Device Sequence Number: 18479456
• Product Code: KRO
• UDI-Device Identifier: 07613327601954
• UDI-Public: 07613327601954
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K251665
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/12/2026

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: 5612-P-611
• Device Lot Number: VN63NR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/04/2025
• 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: 84 YR
• Patient Sex: Male