MAUDE Adverse Event Report: DEPUY SYNTHES / JOHNSON & JOHNSON DEPUY ATTUNE TIBIAL BASEPLATE; PROSTHESIS, KNEE, PATELLOFOMOROTIBIAL, SEMI-CONSTRAINED CEMENTED

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/14/2019

Event Type  Injury  

Event Description

Depuy attune loose tibia baseplate with failure of cement to bond to implant requiring intervention and invasive revision surgery to constrained implants.

• Brand Name: DEPUY ATTUNE TIBIAL BASEPLATE
• Type of Device: PROSTHESIS, KNEE, PATELLOFOMOROTIBIAL, SEMI-CONSTRAINED CEMENTED
• Manufacturer (Section D): DEPUY SYNTHES / JOHNSON & JOHNSON
• MDR Report Key: 8257038
• MDR Text Key: 133561279
• Report Number: MW5083201
• 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: Physician
• Type of Report: Initial
• Report Date: 01/15/2019

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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/16/2019
• 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): Hospitalization; Required Intervention; Disability
• Patient Age: 57 YR
• Patient Weight: 82