MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H HA COATED LAT STEM SIZE 2; CEMENTLESS HIP STEM

Catalog Number 01.18.142

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Joint Disorder (2373)

Event Date 12/13/2017

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 05 january 2018: lot 153982: (b)(4) items manufactured and released on 09 december 2015.Expiration date: 2020-11-24.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.

Event Description

The patient complained hip laxity.1 year and 8 months after primary the surgeon detected a stem subsidence and revised successfully the patient swapping the stem, the head and the liner.

• Brand Name: AMISTEM H HA COATED LAT STEM SIZE 2
• Type of Device: CEMENTLESS HIP 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: 7185279
• MDR Text Key: 97056017
• Report Number: 3005180920-2017-00827
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030804182
• UDI-Public: 07630030804182
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 01/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/24/2020
• Device Catalogue Number: 01.18.142
• Device Lot Number: 153982
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2015
• 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
• Patient Age: 54 YR