MAUDE Adverse Event Report: AAP BIOMATERIALS GMBH SIMPLEX HV WITH GENTAMICIN

Model Number 6195-1-001

Device Problem Human Factors Issue (2948)

Patient Problem Limited Mobility Of The Implanted Joint (2671)

Event Date 12/16/2015

Event Type  Injury  

Event Description

Patient had a knee revision on her left leg on (b)(6) 2015 after experiencing pain and loss of mobility for approximately 11 months.Patient had a bone scan done with revealed that the component was loose.Original implant date was (b)(6) 2014.

• Brand Name: SIMPLEX HV WITH GENTAMICIN
• Type of Device: SIMPLEX HV WITH GENTAMICIN
• 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: 5945999
• MDR Text Key: 54550394
• Report Number: 9615014-2016-00009
• 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
• Reporter Occupation: Health Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 09/12/2016

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?: No
• Device Operator: Physician
• Device Expiration Date: 07/31/2015
• Device Model Number: 6195-1-001
• Device Catalogue Number: 6195-1-010
• Device Lot Number: 334BB920HU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2016
• Initial Date FDA Received: 09/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2013
• 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
• Patient Outcome(s): Other