MAUDE Adverse Event Report: SKYLAR TRIATHLON KNEE; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Device Problems Loss of or Failure to Bond (1068); Nonstandard Device (1420)

Patient Problems Inflammation (1932); Impaired Healing (2378); Unspecified Musculoskeletal problem (4535); Swelling/ Edema (4577)

Event Date 07/07/2021

Event Type  Injury  

Event Description

I had a total knee replacement done on (b)(6) 2021 and since day one it never seemed to heal correctly.As the year almost two years it just continued to get worse: inflammation, stiffness, swelling, inability to move.I saw my surgeon, pa(physician assistant) to surgeon and even had a second and third opinion to be told there wasn't anything wrong with the knee.I was young putting too much stress on it.I became the squeaky wheel, and surgeon finally decided to do a revision and sure enough the cement never bonded with the prosthetic.The brand of prosthetic was recalled earlier in the year march of 2021 before my surgery took place.

• Brand Name: SKYLAR TRIATHLON KNEE
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• MDR Report Key: 17240208
• MDR Text Key: 318299879
• Report Number: MW5119037
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/27/2023

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?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/29/2023
• Patient Sequence Number: 1
• Treatment: AMITRIPYLINE 25 MG ( 2 TABLETS) ; BACLOFEN 10 MG ; CALCIUM; CELECOXIB 200 MG (TWICE DAILY) ; DULOXETINE 60 MG ; FAMOTIDINE 40 MG ; FLUTICASONE NASAL SPRAY TWICE DAILY AS NEEDED ; FOLIC ACID; HUMIRA 40 MG WEEKLY ; HYDROCODONE 10-325 MG ; HYDROXYCHLOROQUINE 200 MG ; INFUSION PUMP.; IRON; LEVOCETIRIZINE 5 MG ; MEDICAL DEVICES: SPINAL STIMULATOR, ; METHOTREXATE 2.5 FOLIC ACID 1 MG; MONTELUKAST 10 MG ; MULTI VITAMIN; MYRBETRIQ 50 MG ; OMEZAPROLE 40 MG ; SOLIFENACIN 10 MG ; SUMATRIPTAN 25 MG ; TAMSULOSIN 0.4 MG (TWICE DAILY) (6 TABLETS EVERY WEEK) ; TURMERIC; VALACYCLOVIR HCL 500 MG ; VITAMIN C & D
• Patient Outcome(s): Other
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White