MAUDE Adverse Event Report: ZIMMER, INC. IMPLANT CEMENT BONE PALACOS (R) 1X40; BONE CEMENT

Lot Number 85214571

Device Problems Loose or Intermittent Connection (1371); Therapeutic or Diagnostic Output Failure (3023); Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 04/26/2017

Event Type  Injury  

Event Description

Requires revision surgery on knee with failed implant due to asceptic loosening.Knee implant was performed using palacos bone cement.Asceptic loosening caused failure of knee implant which now requires revision.Date of surgery: (b)(6) 2017.Did the problem stop after use stopped? no; did the product return if starting taking or using the product again? no.Do you have a picture of the product? no, i did have an mri (b)(6).Company name: mckesson.

• Brand Name: IMPLANT CEMENT BONE PALACOS (R) 1X40
• Type of Device: BONE CEMENT
• Manufacturer (Section D): ZIMMER, INC.
• MDR Report Key: 9266368
• MDR Text Key: 165110117
• Report Number: MW5090832
• Device Sequence Number: 1
• Product Code: LOD
• 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: 10/31/2019
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 85214571
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/31/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention; Disability
• Patient Age: 63 YR
• Patient Weight: 136