MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON REVISION INSERT X3 SZ7 16MM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	5612-X-716
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/22/2025
Type of Reportable Event	Serious Injury
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.The following devices were also listed in this report: device name triathlon hinge b/plate size 7 ; cat# 5612b700; lot# ynb7h.Device name tri cemented stem 12mmx50mm; cat# 5560-s-112; lot# 1195014h.Device name triathlon sym cone aug sz d; cat# 5549-a-140; lot# v2rk1.Device name tri ts femur sz7 left; cat# 5512-f-701 ; lot# ob49i.Device name tri post augment sz7 5mm ; cat# 5543-a-700; lot# ssz9d.Device name triathlon stem extender 25mm; cat# 5571-s-025; lot# 2w5d1m.Device name triathlon cemented stem-15mm x 50mm; cat# 5560-s-115; lot# 1210644e.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: as reported: "rev ltka w/ poly exchange for infection, double dair, will be coming back tuesday for new permanent poly." dair: the insert was removed and patient packed with antibiotic beads as a partial spacer.This will be removed in a second stage.Rep confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: TRIATHLON REVISION INSERT X3 SZ7 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: alessandra chavez ; 3365 enterprise ave; weston, FL 33331 ; 9546280700
• MDR Report Key: 23542945
• Report Number: 0002249697-2025-01332
• Device Sequence Number: 9775970
• Product Code: KRO
• UDI-Device Identifier: 07613327560404
• UDI-Public: 07613327560404
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 11/13/2025

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-716
• Device Lot Number: PM7EPN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/03/2024
• 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: 59 YR
• Patient Sex: Male
• Patient Weight: 135 KG