MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK HINGE TIBIAL AUGMENTATION SIZE 4, 10 MM

Catalog Number 02.09.TA410

Device Problem Incorrect Device Or Component Shipped (2962)

Patient Problem No Information (3190)

Event Date 04/14/2015

Event Type  Injury  

Event Description

The agent opened a 4 x 10 augment and noticed that it was packaged with 5 mm screws.The agent opened another 4 x 10 augment and the same problem occurred.In order to obtain 10 mm screws to implant the augment the agent had to open a 2 x 10 mm augment.The surgeon used the 10 mm screws from the 2 x 20 mm implant.Mfr ref # 3005180920-2015-00087.

• Brand Name: GMK HINGE TIBIAL AUGMENTATION SIZE 4, 10 MM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; castel san pietro ; SZ
• Manufacturer (Section G): MEDACTA USA INC.; 1556 w carroll ave; chicago IL 60607 0000
• Manufacturer Contact: 1556 w carroll ave; chicago, IL 60607-0000
• MDR Report Key: 4774924
• MDR Text Key: 5782433
• Report Number: 3006639916-2015-00087
• Device Sequence Number: 1
• Product Code: KRO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 05/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 02.09.TA410
• Device Lot Number: 145129
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/28/2015
• Distributor Facility Aware Date: 04/14/2015
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/28/2015
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other