MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H, HA COATED STEM SIZE 2 STD; CEMENTLESS FEMORAL STEM

Catalog Number 01.18.132

Device Problem Failure To Adhere Or Bond (1031)

Patient Problems Pain (1994); Joint Disorder (2373)

Event Date 05/15/2017

Event Type  Injury  

Manufacturer Narrative

Additional information received on 18 may 2017 and includes: the surgery has been rescheduled for (b)(6) 2017.The surgeon plans to revise the stem, head and liner.Additional information received on 26 may 2017 and includes: the revision surgery was completed successfully.Batch review performed on 12 june 2017.(b)(4).On 12 june 2017 the medical affairs director performed a clinical evaluation and commented as follows: partial revision of cementless tha after 4 years.The information available does not allow any conclusion to be drawn.One very low quality x-ray picture is supplied and shows a clear distal pedestal, along with radiolucencies along the stem.These findings are compatible with a painful loose stem, but the causes cannot be determined.

Event Description

The patient came in complaining of pain.The surgeon determined that the stem was loose.The surgeon plans to revise the stem, head and liner.

• Brand Name: AMISTEM H, HA COATED STEM SIZE 2 STD
• 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
• MDR Report Key: 6640052
• MDR Text Key: 77536401
• Report Number: 3005180920-2017-00301
• 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: 06/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Catalogue Number: 01.18.132
• Device Lot Number: 125395
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/15/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/18/2013
• 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
• Patient Outcome(s): Required Intervention