MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 5 TRIATH TS PLUS TIB INS X3 POLY 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5537-G-509-E
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
As per medwatch mw5186904: stryker triathlon x3 total stabilizer tibial insert - defective implant - wire popped out and plastic split from component on first contact with impactor.Update: initial reporter confirmed a clinical specialist was present for the event.

• Brand Name: NO 5 TRIATH TS PLUS TIB INS X3 POLY 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: 25229465
• Report Number: 0002249697-2026-00430
• Device Sequence Number: 15998242
• Product Code: MBH
• UDI-Device Identifier: 07613327288353
• UDI-Public: 07613327288353
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K172634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 5537-G-509-E
• Device Lot Number: V80DVY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/23/2024
• 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
• Patient Age: 82 YR
• Patient Sex: Female