MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATH SOLID CR TIB INS TRL SZ 5 - 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	5530-T-509Y
Medical Device Problem Codes	Fracture (1260); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Posterior part of the trial inlay broke.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a triathlon trial was reported.The event was confirmed via review of the returned device.Method & results: product evaluation and results: visual inspection & material analysis: review of the triathlon solid cr tibial insert trial size 5, catalogue#: 5530-t-509y, lot code: a242r confirmed fracture on the posterior articulating surface edge.Characterisation using stereo microscopy confirmed fracture on the posterior articulating surface edge due to overload fracture.No manufacturing or material related defects were observed on the fracture surfaces examined.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the product history records indicate the reported device was manufactured with no reported relevant discrepancies.Complaint history review: there have been 1 other similar events for the lot referenced.Conclusions: it was reported that the trial broke during surgery.Visual inspection & material analysis: review of the triathlon solid cr tibial insert trial size 5, catalogue#: 5530-t-509y, lot code: a242r confirmed fracture on the posterior articulating surface edge.Characterisation using stereo microscopy confirmed fracture on the posterior articulating surface edge due to overload fracture.No manufacturing or material related defects were observed on the fracture surfaces examined.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
No new information.

• Brand Name: TRIATH SOLID CR TIB INS TRL SZ 5 - 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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: 23720336
• Report Number: 0002249697-2025-01410
• Device Sequence Number: 21041607
• Product Code: JWH
• UDI-Device Identifier: 07613327402544
• UDI-Public: 07613327402544
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K173849
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2026

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: 5530-T-509Y
• Device Lot Number: A242R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2025
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown