MAUDE Adverse Event Report: AAP BIOMATERIALS GMBH SIMPLEX HV WITH GENTAMICIN US 1 PACK; SIMPLEX HV GENTAMICIN

Catalog Number 6195-1-001

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

Patient Problems No Known Impact Or Consequence To Patient (2692); Missing Value Reason (3192)

Event Date 11/23/2015

Event Type  malfunction  

Manufacturer Narrative

Device not returned, retain sample will.

Event Description

Upon following proper protocol mixing up 1st batch of simplex p, the dr encountered inconsistent "working" phase of cement while implanting the tibial component.A second batch was mixed and the dr reported the cement went into "set up" phase and was unable to use it.Then a batch of simplex hv batch was mixed and deemed unusable as well.

• Brand Name: SIMPLEX HV WITH GENTAMICIN US 1 PACK
• Type of Device: SIMPLEX HV GENTAMICIN
• Manufacturer (Section D): AAP BIOMATERIALS GMBH; lagerstr.11-15; dieburg, 64807 ; GM 64807
• Manufacturer (Section G): AAP BIOMATERIALS GMBH; lagerstr.11-15; dieburg 64807 ; GM 64807
• Manufacturer Contact: lydia heimann ; lagerstr. 11-15; dieburg, 64807 ; GM 64807 ; 071929107
• MDR Report Key: 5338421
• MDR Text Key: 34806314
• Report Number: 9615014-2015-00007
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K12308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/13/2017
• Device Catalogue Number: 6195-1-001
• Device Lot Number: 520BB853
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2014
• 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): Required Intervention