MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INS #8 13MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5531G813

Device Problem Unstable (1667)

Patient Problems Pain (1994); Joint Laxity (4526)

Event Date 05/05/2023

Event Type  Injury  

Event Description

Customer reported: "from the very first post-operative period, the patient has always complained of pain and joint instability in the operated right knee.After evaluation at our clinics which confirmed the joint instability, on (b)(6) 2023 the patient underwent total prosthetic reimplantation.The removed prosthetic components appeared neat, with no marks or other mechanical complication.This report is sent with delay compared to the usual times due to computer error/(pre-filled report, but subsequently missing sending to the competent offices).Planting date (b)(6) 2022 (day not known).The report concerns the entire implantation of knee prostheses.".

Manufacturer Narrative

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.The following devices were also listed in this report: triathlon cr beaded fem #7r; cat # 5513f702; lot # nlt7e, tritanium bplate triathlon s8; cat # 5536b800; lot # ctd64103.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.H3 other text : not available.

• Brand Name: X3 TRIATHLON CS INS #8 13MM
• Type of Device: 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: 18859300
• MDR Text Key: 337143655
• Report Number: 0002249697-2024-00352
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327046434
• UDI-Public: 07613327046434
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 5531G813
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 39 YR