MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED STD STEM SIZE 1; CEMENTLESS HIP STEM

Model Number 01.18.131

Device Problem Osseointegration Problem (3003)

Patient Problem Insufficient Information (4580)

Event Date 12/01/2020

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 10 december 2020 lot 140745: 100 items manufactured and released on 23-apr-2014.Expiration date: 2019-03-31.No anomalies found related to the problem.To date,all items of the same lot have been already sold with one similar event reported since 2016.

Event Description

The surgeon performed a revision (6 years and 3 months after primary surgery) on the right hip of the patient due to an aseptic loosening.Stem and head have been successfully revised.

Manufacturer Narrative

Visual inspection performed by medacta r&d department: visual inspection performed on 19th january 2021.No particular signs were noticed on the stem and head; some little signs on the spherical surface of the ceramic ball head are probably related to the revision surgery, while the stem was completely uncovered from ha, indicator of proper osseointegration.From the received information the root cause of the event remains unknown, but aseptic loosening is common between the adverse events described in literature after primary cementless hip arthroplasties.

• Brand Name: STEM: AMISTEM H HA COATED STD STEM SIZE 1
• Type of Device: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11087667
• MDR Text Key: 224073476
• Report Number: 3005180920-2020-00951
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030804076
• UDI-Public: 07630030804076
• Combination Product (y/n): N
• PMA/PMN Number: K093944
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/18/2021

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: 03/31/2019
• Device Model Number: 01.18.131
• Device Catalogue Number: 01.18.131
• Device Lot Number: 140745
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Initial Date Manufacturer Received: 11/29/2020
• Initial Date FDA Received: 12/29/2020
• Supplement Dates Manufacturer Received: 11/29/2020
• Supplement Dates FDA Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR