MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM BPLATE TRIATHLON S2; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number 5536-B-200

Device Problems Loss of Osseointegration (2408); Noise, Audible (3273)

Patient Problem Inadequate Osseointegration (2646)

Event Date 03/01/2023

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.

Event Description

Patient reported joint loosening and audible noise following primary triathlon left knee surgery.Patient stated that symptoms started "immediately" following the (b)(6) 2020 surgery and that the knee was"never good".Patient stated she feels the loosening and did not state whether her surgeon confirmed the loosening.Patient stated that the joint noise is heard when she moves her "toes up and down".

• Brand Name: TRITANIUM BPLATE TRIATHLON S2
• 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16619645
• MDR Text Key: 312044769
• Report Number: 0002249697-2023-00308
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327041590
• UDI-Public: 07613327041590
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/27/2023

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
• Device Operator: Health Professional
• Device Model Number: 5536-B-200
• Device Catalogue Number: 5536B200
• Device Lot Number: CTD37635
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/01/2023
• Initial Date FDA Received: 03/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2019
• 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): Other
• Patient Sex: Female