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

Model Number 6195-1-001

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191); Missing Value Reason (3192)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 10/20/2016

Event Type  Injury  

Manufacturer Narrative

Device not available for evaluation.

Event Description

Per patient, his primary surgery was done in approximately (b)(6) 2015.He would walk and fall.The surgeon stated that there was too much movement in the implant.He indicated that it was loose and revised the patient on (b)(6) 2016.Patient stated he has had ongoing pain.He has had difficulty walking.Left knee.This report is for pain after revision in (b)(6) 2016.

• 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: 6205971
• MDR Text Key: 63311880
• Report Number: 9615014-2016-00011
• 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: consumer,distributor,foreign
• Reporter Occupation: Patient
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 12/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/30/2017
• Device Model Number: 6195-1-001
• Device Catalogue Number: 6195-1-010
• Device Lot Number: 526BA881FW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2015
• 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
• Treatment: NO 7. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 25MM; STERILE FLUTED HEADLESS 1/8" PIN 3.5" LONG; TRI PRESS-FIT STEM 15X150MM; TRI PRESS-FIT STEM 18X150MM; TRI TS BASEPLATE SIZE 7; TRI TS FEMUR SZ7 LEFT; TRIATHLON TOTAL KNEE SYSTEM OFFSET ADAPTER 6MM
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Weight: 129