MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON #3 PS INSERT 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5532P311
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577)
Date of Event	02/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: triathlon prim tib bplate cemented sz 3; cat # 5520-b-300; lot # e7o3vb; triathlon ps fem component cemented; cat # 5515-f-401; lot # eyz9ia; triathlon sym patella s27x8mm; cat # 5550l278; lot # ljx041; surgical simplex cement; cat # 61910001; lot # cac008.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 devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
The following was reported: it was reported, by a family member of a patient, that a patient which had knee implant implanted in (b)(6) 2021 experienced continuous pain, accompanied by severe inflammation, extreme swelling (twice the normal size), heat in the area and reduced mobility after surgery.Since then, the patient has been unable to leave the walker.Before surgery, during the wait time of for the surgery, walkers and crutches were used to walk.It was reported that a doctor referred the patient to several specialists and tests but found no clear cause for the condition.In (b)(6) 2024, the pain in the other knee became severe, and she was given fentanyl to control it.From that moment on, it was noticed relief in the operated knee.On (b)(6) 2025 the patient underwent a second knee surgery (the other knee) with a prosthesis from another company.A difference was noted between the first and this new operation, which has evolved without the problems experienced on the first intervention.Currently, the patient is still taking fentanyl.

• Brand Name: TRIATHLON #3 PS INSERT 11MM
• 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: 21503577
• Report Number: 0002249697-2025-00254
• Device Sequence Number: 4400375
• Product Code: MBH
• UDI-Device Identifier: 07613327042665
• UDI-Public: 07613327042665
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/03/2025

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: 04/30/2023
• Device Catalogue Number: 5532P311
• Device Lot Number: LHK804
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/27/2018
• 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 Sex: Female