MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATH SOLID CS TIB INS TRL SZ 6 - 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5531-T-609Y
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Broke the 6x9mm poly trial when extracting after trialing.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a triathlon trial was reported.The event was confirmed via visual inspection of the returned device.Method & results: -product evaluation and results: visual inspection of the returned device indicates surface damage is present with a fractured posterior edge.Examination of the returned device with engineer indicated that the device is fractured due to an overload condition as indicated by hackles observed on fracture surface.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.-clinician review: no medical records were received for review with a clinical consultant.-device history review: could not be performed as lot code information was not provided.-complaint history review: could not be performed as lot code information was not provided.Conclusions: it was reported that 'broke the 6x9mm poly trial when extracting after trialing'.Visual inspection of the provided photograph show a trial triathlon insert with evidence of the posterior edge of the device being fractured off.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
No additional information.

• Brand Name: TRIATH SOLID CS TIB INS TRL SZ 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: alessandra chavez ; 3365 enterprise ave; weston, FL 33331 ; 9546280700
• MDR Report Key: 23592791
• Report Number: 0002249697-2025-01345
• Device Sequence Number: 9925045
• Product Code: MBH
• UDI-Device Identifier: 07613327402711
• UDI-Public: 07613327402711
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K173849
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2026

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: 5531-T-609Y
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2025
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Male