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 09/26/2016

Event Type  Injury  

Manufacturer Narrative

Device not available for evaluation.

Event Description

Per sales rep, patient had knee pain.The doctor believed the tibia implant was loose.The bolt at the bottom of the base plate was loose and had grey debris.The doctor believed it to be metallosis.This report is for pain which has caused the revision.

• 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: 6266247
• MDR Text Key: 65373413
• Report Number: 9615014-2017-00012
• 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: Physician
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 01/20/2017

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: 06/30/2015
• Device Model Number: 6195-1-001
• Device Catalogue Number: 6195-1-010
• Device Lot Number: 333BA910GU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/28/2016
• Initial Date FDA Received: 01/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• 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: TRI TS BASEPLATE SIZE 4 CAT. NO: 5521-B-400; TRIATHLON PS FEM COMPONENT, CEMENTED (CAT. NO: 551; TRIATHLON PS X3 TIBIAL INSERT (CAT. NO: 5532-G-409; TRIATHLON SYMMETRIC X3 PATELLA (CAT. NO: 5550-G-33
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Weight: 60