MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H CEMENTLESS STEM SIZE 3 LAT; FEMORAL CEMENTLESS STEM

Catalog Number 01.18.143

Device Problem Material Deformation (2976)

Patient Problem Pain (1994)

Event Date 10/30/2014

Event Type  Injury  

Event Description

On 50 days after the surgery, pt had pain.The implant sunk in and it was revised.Mfr ref #3005180920-2014-00166.

• Brand Name: AMISTEM H CEMENTLESS STEM SIZE 3 LAT
• Type of Device: FEMORAL CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; castel san pietro ; SZ
• Manufacturer (Section G): MEDACTA USA INC.; 1556 w carroll ave; chicago IL 60607 000
• Manufacturer Contact: 1556 w carroll ave; chicago, IL 60607-0000
• MDR Report Key: 4297014
• MDR Text Key: 5273238
• Report Number: 3006639916-2014-00166
• Device Sequence Number: 1
• Product Code: LZO
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 11/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 01.18.143
• Device Lot Number: 136200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/26/2014
• Distributor Facility Aware Date: 11/12/2014
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/26/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention