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

Device Problems Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Edema (1820); Bone Fracture(s) (1870); Pain (1994); Loss of Range of Motion (2032)

Event Date 09/27/2016

Event Type  malfunction  

Event Description

Replaced faulty knee device; had total left knee replacement with depuy attune system.Left knee never "felt right".Other issues were - pain when putting weight on the knee, buildup of fluid in the joint, limited range of motion in the knee, loosening of the knee joint, fractures of the device, early wear on the joint had total left knee replacement in (b)(6) 2020 to remove depuy attune system and a different device was used.Fda safety report id# (b)(4).

• Brand Name: DEPUY ATTUNE
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE B
• Manufacturer (Section D): JOHNSON & JOHNSON MEDICAL (DEPUY - SUZHOU) LTD
• MDR Report Key: 11332549
• MDR Text Key: 232215777
• Report Number: MW5099395
• Device Sequence Number: 1
• Product Code: JWH
• 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: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/12/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Weight: 91