MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON REVISION INSERT X3 SZ3 16MM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	5612-X-316
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.The following devices were also listed in this report: device name# tri ts femur sz2 left; cat# 5512-f-201; lot# sel3u, device name# triathlon femoral distal augment 15mm - size 2 left; cat# 5542-a-201; lot# ssd3u, device name# triath fem distal aug 5mm - size 2 left; cat# 5540-a-201; lot# sae3b, device name# tri post augment sz2 5mm; cat# 5543-a-200; lot# rux4r, device name# tri post augment sz2 5mm ; cat# 5543-a-200; lot# rux4r, device name# tri cemented stem 12mmx50mm ; cat# 5560-s-112; lot# 1194514h, device name# tri cemented stem 12mmx50mm ; cat# 5560-s-112; lot# 1194510j, device name# triathlon hinge b/plate size 3 ; cat# 5612b300; lot# s932h, device name# triathlon revision tibaug sz3 lm rl 5mm ; cat# 5612-a-351; lot# y240vm, device name# triathlon revision tibaug sz3 rm ll 5mm; cat# 5612-a-350; lot# 808nah.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
I&d with tibial insert exchange of a left revision triathlon due to infection.

• Brand Name: TRIATHLON REVISION INSERT X3 SZ3 16MM
• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22858988
• Report Number: 0002249697-2025-00901
• Device Sequence Number: 21139916
• Product Code: KRO
• UDI-Device Identifier: 07613327559958
• UDI-Public: 07613327559958
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K230416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/21/2025

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-X-316
• Device Lot Number: 1H2P76
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/17/2024
• 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 Age: 66 YR
• Patient Sex: Female