MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED LAT STEM SIZE 4; CEMENTLESS STEM

Model Number	01.18.144
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	11/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Amistem implanted approximately 6 years ago.Revision surgery performed due to aseptic loosening.Waiting for info regarding revision.
Additional Manufacturer Narrative
Device to be received and analyzed.X-rays analysis to be performed.Additional information and results of the analysis could be available in this case follow up 1.
Additional Manufacturer Narrative
Batch review performed on 9 january 2023: lot 112384: 10 items manufactured and released on 05-sep-2011.Expiration date: 2016-jul-31.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by medical affairs department revision approximately 6 years after index surgery in a male patient due to aseptic loosening.From the images, signs of stress shielding and radiographic loosening are visible.Aseptic loosening is a possible literature described adverse event after primary cementless hip arthroplasties and its causes are often unknown.The reason for this failure cannot be determined.Visual inspection performed by r&d project manager during the analysis it was evaluated that almost the proximal half of the stem body is still covered with ha coating.This in unexpected considering that the stem was implanted six years ago.Some signs and scratches are present on the neck surface, probably due to revision surgery.It is not possible to determine the root cause of reported loosening.
Event or Problem Description
Revision surgery performed approximately 10 years after the primary surgery due to aseptic loosening.

• Brand Name: STEM: AMISTEM H HA COATED LAT STEM SIZE 4
• Common Device Name: CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15860278
• Report Number: 3005180920-2022-00870
• Device Sequence Number: 5716952
• Product Code: LZO
• UDI-Device Identifier: 07630030804205
• UDI-Public: 07630030804205
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2016
• Device Model Number: 01.18.144
• Device Catalogue Number: 01.18.144
• Device Lot Number: 112384
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2022
• Supplement Date Received by Manufacturer: 10/29/2022
• Initial Report FDA Received Date: 11/24/2022
• Supplement Report FDA Received Date: 02/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2011
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown