MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H, COLLARED HA COATED STEM SIZE 5 STD; CEMENTLESS FEMORAL STEM

Catalog Number 01.18.235

Device Problem Contamination (1120)

Patient Problem Unspecified Infection (1930)

Event Date 03/24/2017

Event Type  Injury  

Manufacturer Narrative

Batch reviews performed on 24 april 2017.Lot 156255: (b)(4) items manufactured and released on 18 february 2016.Expiration date: 2021-02-06.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Cocr ball head 12/14 ø 28 size s -3.5, code 01.25.011, lot.162045 (k072857), (b)(4) items manufactured and released on 22 april 2016.Expiration date: 2021-04-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Bipolar head ø28x47, code 25060.2847, lot.151033 (k091967), (b)(4) items manufactured and released on 03 june 2015.Expiration date: 2020-04-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.

Event Description

The patient came in due to signs of infection.The pathogen is unknown.The surgeon removed all medacta components and implanted an antibiotic spacer.The surgery was completed successfully.X-rays and explants are not available.

• Brand Name: AMISTEM H, COLLARED HA COATED STEM SIZE 5 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: 6515525
• MDR Text Key: 73493436
• Report Number: 3005180920-2017-00204
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K121011
• 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: 04/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/06/2021
• Device Catalogue Number: 01.18.235
• Device Lot Number: 156255
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/25/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/18/2016
• 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