MAUDE Adverse Event Report: AAP BIOMATERIALSGMBH SIMPLEX HV WITH GENTAMICIN

Model Number 6195-1-001

Device Problem Contamination (1120)

Patient Problem Unspecified Infection (1930)

Event Date 06/20/2016

Event Type  Injury  

Manufacturer Narrative

Not returned to manufacturer.

Event Description

The hospital had an infected joint after implantation of antibiotic bone cement during a primary tka implantation.The hospital are wanting to make sure do not have any issues with the particular lot code.

• Brand Name: SIMPLEX HV WITH GENTAMICIN
• Type of Device: SIMPLEX HV WITH GENTAMICIN
• Manufacturer (Section D): AAP BIOMATERIALSGMBH; lagertsrasse 11-15; dieburg, 64807 ; GM 64807
• Manufacturer (Section G): AAP BIOMATERIALS GMBH; lagertsrasse 11-15; dieburg, 64807 ; GM 64807
• Manufacturer Contact: volker stirnal ; lagerstrasse 11-15; dieburg, 64807 ; GM 64807 ; 9607192922
• MDR Report Key: 5889991
• MDR Text Key: 52561040
• Report Number: 9615014-2016-00006
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 04260056885761
• UDI-Public: 04260056885761
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 07/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 07/31/2017
• Device Model Number: 6195-1-001
• Device Catalogue Number: 6195-1-010
• Device Lot Number: 530BB987GW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2015
• 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
• Patient Outcome(s): Other