MAUDE Adverse Event Report: AAP BIOMATERIALS GMBH CARDINAL HEALTH ARTHROPLASTY BONE CEMENT

Model Number CMT-40-1

Device Problems Inadequate or Insufficient Training (1643); Device Handling Problem (3265)

Patient Problems Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)

Event Date 11/28/2016

Event Type  malfunction  

Manufacturer Narrative

Device not available for evaluation.

Event Description

Mixinng time: 90 seconds; bone cement implantation after 2:38 minutes; tibia plate implantation after 3:30 minutes; curing time 15 minutes (longer than expected); delay in surgery (some minutes).

• Brand Name: CARDINAL HEALTH ARTHROPLASTY BONE CEMENT
• Type of Device: CARDINAL HEALTH ARTHROPLASTY BONE CEMENT
• Manufacturer (Section D): AAP BIOMATERIALS GMBH; lagerstrasse 11-15; dieburg, 64807 ; GM 64807
• Manufacturer (Section G): AAP BIOMATERIALS GMBH; lagerstrasse 11-15; dieburg, 64807 ; GM 64807
• Manufacturer Contact: volker stirnal ; lagerstrasse 11-15; dieburg, 64807 ; GM 64807 ; 9607192922
• MDR Report Key: 6325161
• MDR Text Key: 67209166
• Report Number: 9615014-2017-00017
• Device Sequence Number: 1
• Product Code: LOD
• UDI-Device Identifier: 10885380066511
• UDI-Public: 10885380066511
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123225
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 02/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/30/2017
• Device Model Number: CMT-40-1
• Device Catalogue Number: CMT-40-1
• Device Lot Number: 15FA52050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: (B)(4) CARTRIDGE MIXING SYSTEM
• Patient Outcome(s): Hospitalization
• Patient Age: 50 YR
• Patient Weight: 70