MAUDE Adverse Event Report: PALACOS CEMENT

Device Problems Bent (1059); Device Slipped (1584)

Patient Problem Failure of Implant (1924)

Event Date 07/05/2011

Event Type  Injury  

Event Description

The palacos cement was debonding from the cement and prosthesis.All components had to be cemented into place with other item and medicines.Dr (b)(6) put in clinic note - hardware failure.Knee could not bend, after the femoral and tibial component became grossly loose.

• Brand Name: PALACOS CEMENT
• Type of Device: PALACOS CEMENT
• MDR Report Key: 5652266
• MDR Text Key: 45229163
• Report Number: MW5062239
• Device Sequence Number: 1
• Product Code: LOD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 64