MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H HA COATED LAT STEM SIZE 3; HIP CEMENTLESS STEM

Model Number	01.18.143
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	04/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 29 april 2022: lot 160757: (b)(4) items manufactured and released on 20-may-2016.Expiration date: 2021-05-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event since 2018.Clinical evaluation performed by clinical affairs specialist: hip revision surgery performed 5 years after total hip arthroplasty.Radiographic image provided shows the presence of radiolucent lines in zones 1 and 7.No information concerning patient general health status and the presence of comorbidities is available.Aseptic loosening is a possible literature described adverse event after primary cementless hip arthroplasties and causes are often unknown.The reason of this failure cannot be determined.Hip r&d project manager pictures analysis: looking at the image of the stem attached to the complaint it is visible that the explanted stem is covered with patient blood.It seems that no signs of ha coating are present, even if it is not easy to evaluate.Additional info will be added during the visual inspection analysis if the stem will be available.It is not possible to determine the root cause of stem loosening.
Event or Problem Description
At 5 years 1 month after the primary, revision surgery following the aseptic loosening of the stem due to insufficient osseointegration.The surgeon revised successfully the stem, head and liner.
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager.During the analysis it is evaluated that almost proximal half of the stem is still covered with ha coating.This is unexpected after 5 years of implantation, meaning that the stem was not correctly osseointegrated with the patient bone.Some signs and scratches are present on the neck part probably due to revision surgery.It is not possible to determine the root cause of incorrect osseointegration and asepting loosening.

• Brand Name: AMISTEM H HA COATED LAT STEM SIZE 3
• Common Device Name: HIP CEMENTLESS 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, switzerland 6874 ; SZ 6874
• MDR Report Key: 14486028
• Report Number: 3005180920-2022-00401
• Device Sequence Number: 5321548
• Product Code: LZO
• UDI-Device Identifier: 07630030804199
• UDI-Public: 07630030804199
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 06/21/2022

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: 05/03/2021
• Device Model Number: 01.18.143
• Device Catalogue Number: 01.18.143
• Device Lot Number: 160757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2022
• Supplement Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 05/24/2022
• Supplement Report FDA Received Date: 06/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2016
• 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 Age: 54 YR
• Patient Sex: Male
• Patient Weight: 106 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White