MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM C CEMENTED STD STEM SIZE 2; CEMENTED HIP STEM

Catalog Number 01.18.152

Device Problem Sticking (1597)

Patient Problem Joint Disorder (2373)

Event Date 12/27/2017

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 24 january 2018 lot 156204: (b)(4) items manufactured and released on 01 december 2015.Expiration date: 2020-11-21 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

One year after primary the surgeon revised the patient for a stem loosening.

• Brand Name: AMISTEM C CEMENTED STD STEM SIZE 2
• Type of Device: CEMENTED 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: 7221029
• MDR Text Key: 98288359
• Report Number: 3005180920-2018-00006
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030804274
• UDI-Public: 07630030804274
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103189
• 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: 01/26/2018

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: 11/21/2020
• Device Catalogue Number: 01.18.152
• Device Lot Number: 156204
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/29/2017
• Initial Date FDA Received: 01/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2015
• 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