MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON #5 PS ALLPOLY 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5535A509
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	09/19/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was provided: the subject experienced post-operative arthrofibrosis, occurring in the post-operative period.Due to limited range of motion beforehand, a manipulation under anesthesia was performed.The event was not device-related, and did not result in death.
Additional Manufacturer Narrative
The following devices were also listed in this report: triathlon ps fem component cemented; cat # 5515-f-601; lot # updguawb triathlon sym patella s33x9mm; cat # 5550l339; lot # lha758.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There has been similar event(s) for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

• Brand Name: TRIATHLON #5 PS ALLPOLY 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-LIMERICK; raheen business park; limerick NA ; EI NA
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 24938359
• Report Number: 0002249697-2026-00322
• Device Sequence Number: 14791675
• Product Code: MBH
• UDI-Device Identifier: 07613327043617
• UDI-Public: 07613327043617
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/21/2026

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: 11/30/2018
• Device Catalogue Number: 5535A509
• Device Lot Number: 236676
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/18/2013
• 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: Other
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 85 KG
• Patient Ethnicity: Hispanic