MAUDE Adverse Event Report: JOHNSON & JOHNSON MEDICAL (DEPUY - SUZHOU) LTD. DEPUY ATTUNE KNEE REPLACEMENT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Pain (1994); Ambulation Difficulties (2544)

Event Date 03/09/2020

Event Type  Injury  

Event Description

Difficulty in walking after sitting or riding.Pain in tibia just below knee replacement.Had knee replaced (b)(6) 2015 and j&j depuy attune was the replacement knee.The issue is that the cement holding a piece to the tibia loosened.Due to covid i had difficulty in being seen by a dr and received 2 incorrect diagnoses until (b)(6) of 2020 when my orthopedist looked at the xray taken in april and called me with the correct diagnosis and told me i would need to make an appointment with a surgeon who does revision surgery.I have spent over 6 months in pain and have had different appointments trying to get an answer as to why i can't walk.Currently i cannot walk without a cane or walker and i walk in constant pain; i cannot walk comfortably for any length of time or distance; my leg is bowed and i can move the knee laterally.I have an appointment with an orthopedist who does revision surgery in the near future.I have had 2 ultra sounds on the veins in my leg due to a misdiagnosis and blood work due to complaints re the pain.Since these are not related to the actual problem, i am not listing dates etc.I also had physical therapy for 4 weeks which was not helpful.Fda safety report id# (b)(4).

• Brand Name: DEPUY ATTUNE KNEE REPLACEMENT
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): JOHNSON & JOHNSON MEDICAL (DEPUY - SUZHOU) LTD.; no.299, changyang street ; suzhou industrial park; suzhou jiangsu CN 21 5126; CH CN 215126
• MDR Report Key: 10648866
• MDR Text Key: 210630971
• Report Number: MW5097143
• Device Sequence Number: 1
• Product Code: KRR
• 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: 10/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR