MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5532-G-709-E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Ansm reported that: "following surgery for total prosthesis of the right knee, an infection appeared after removal of the staples around around 04/25/2024, and a red spot appeared which suppurated at the level of the scar.Since then, the surgeon was informed of this and saw me again to perform an operation to open, remove and wash the wound, as well as change the clip-on part.And to change the clip-on part of the prosthesis.This operation took place on (b)(6) 2024, after which i was placed under monitoring at the clinic and under treatment ever since.To date, on 05/14/2024, i'm still on antibiotics, which have been reinforced since 05/11/2024, but i still have a fever.Samples have revealed the presence of bacilli and staphylococci in my organism, and i'm still waiting for the results of the 3 samples patient's current condition: my general condition: weight loss (about 8 kg), severe fatigue due to lack of sleep, nutritional deficiencies.I am requesting transfer to a hospital specializing in infectious diseases related to the fitting of prostheses.Prostheses.Actions taken in the care facility to manage the patient: nr".
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no similar events for the lot referenced.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.The following devices were also listed in this report: cat# 5516f702; triathlon p/a ps beaded #7r; lot# tbh4b cat# 5536b700; tritanium bplate triathlon s7; lot# ctd103529a cat# 5556-l-360; tritanium patella-symmetric; lot# v6xn1 it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

• Brand Name: TRIATHLON PS X3 TIBIAL INSERT
• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19498050
• Report Number: 0002249697-2024-00862
• Device Sequence Number: 18135905
• Product Code: MBH
• UDI-Device Identifier: 07613327338010
• UDI-Public: 07613327338010
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K172634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/10/2024

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 Catalogue Number: 5532-G-709-E
• Device Lot Number: V48YWM
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/21/2024
• Initial Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/12/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown