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

Catalog Number 01.18.143

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 05/26/2016

Event Type  Injury  

Manufacturer Narrative

Additional information received on 07 june 2016 and includes: it is unknown if the patient had some trauma that could have caused the event.Batch reviews performed on 22 june 2016.(b)(4).

Event Description

The patient came in due to feeling unstable.The surgeon revised stem, head and liner.The surgery was completed successfully.X-rays and explants are not available.

• Brand Name: AMISTEM H, HA COATED STEM SIZE 3 LAT
• Type of Device: CEMENTLESS FEMORAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, 6874 ; SZ 6874 ; 91 6966060
• MDR Report Key: 5747918
• MDR Text Key: 48112790
• Report Number: 3005180920-2016-00312
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K093944
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/24/2016

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: Health Professional
• Device Expiration Date: 12/31/2016
• Device Catalogue Number: 01.18.143
• Device Lot Number: 115072
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/26/2016
• Initial Date FDA Received: 06/24/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/14/2012
• 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