MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT NO 6 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5531-G-609-E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	01/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.The following devices were also listed in this report: triathlon prim tib bplate cemented sz 6; cat#: 5520-b-600; lot#: g9v4ya.Triathlon cr fem comp #6 r-cem; cat#: 5510f602; lot#: jd97l.Triathlon asymmetric x3 patella; cat#: 5551-g-299-e ; lot#: 6a5r.Sterile fluted headless 1/8 pin x 3.5 in; cat#: 7650-2038a ; lot#: sc29878a5.Simplex hv us 1 pack; cat#: 6194-1-001; lot#: 015aa885fb.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
Patient alleges allergic reaction and pending revision for both of his knee replacements.This report is for the right knee.

• Brand Name: X3 TRIATHLON CS INSERT NO 6 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21373394
• Report Number: 0002249697-2025-00194
• Device Sequence Number: 8432221
• Product Code: MBH
• UDI-Device Identifier: 07613327337402
• UDI-Public: 07613327337402
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K172634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/13/2025

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 Expiration Date: 06/30/2026
• Device Catalogue Number: 5531-G-609-E
• Device Lot Number: T35JHK
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/24/2021
• 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: 78 YR
• Patient Sex: Male