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

Catalog Number 01.18.233

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Joint Disorder (2373)

Event Date 10/06/2017

Event Type  Injury  

Manufacturer Narrative

On 20 october 2017 the medical affairs performed a clinical evaluation and commented as follows: subsidence of collared femoral stem 2 days after primary cementless tha.The causes for subsidence are not known; one possibility is stem undersizing and insufficient cortical contact, but bone conditions may also play a role.Only one radiographical projection is available, insufficient for full assessment.This type of problem should not be ascribed to a faulty implant.Batch review performed on 30 october 2017.Lot 171636: (b)(4) items manufactured and released on 28 june 2017.Expiration date: 2022-05-16.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 stem had subsided.The cause of the stem subsiding is unknown.The surgeon revised the stem, head and liner.The surgery was completed successfully.

• Brand Name: AMISTEM COLLARED, HA COATED STEM SIZE 3 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: 6990608
• MDR Text Key: 90683115
• Report Number: 3005180920-2017-00629
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030804588
• UDI-Public: 07630030804588
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 10/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/16/2022
• Device Catalogue Number: 01.18.233
• Device Lot Number: 171636
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/06/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/28/2017
• 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: 67 YR