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

Catalog Number UNK_JR

Device Problems Unstable (1667); Noise, Audible (3273)

Patient Problems Pain (1994); Ambulation Difficulties (2544); Swelling/ Edema (4577)

Event Date 12/05/2023

Event Type  Injury  

Event Description

Letter received from patient: "on (b)(6) 2022, i had my left knee replaced with a stryker triathlon size 4 femur and triathlon size 5 tibia and stryker cs poly insert 9mm using a femoral distal cutting guide and an intra-medullary guide for the tibia.A follow-up x-ray date (b)(6) 2023 under history remarked "left knee pain and left hip pain" with findings stating "no evidence of complication.There is no acute fracture or dislocation.Soft tissue are unremarkable." on a second x-ray dated (b)(6) 2023 under history remarked "instability of joint with pain; pain" and with findings stating "no periprosthetic fracture or dislocation.Soft tissue swelling.Joint effusion." i now experience joint instability, chronic pain even down to my shin bone and mobility limitations and accompanied by very audible "popping sounds" occurring during any for of weight transfer while using my walker which has been verified and documented by multiple medical staff including the surgeon who performed the operation procedure.My question to you is this, "is there any chance the surgeon was using a recalled cutting guide or was she simply mis-using the correct updated version and is my knee arthroplasty in a state of deterioration which will eventually warrant replacement?".

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.

• Brand Name: UNKNOWN TRIATHLON KNEE
• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18823524
• MDR Text Key: 336739474
• Report Number: 0002249697-2024-00333
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/07/2024
• 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): Other
• Patient Sex: Male