MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED STD STEM SIZE 0; CEMENTLESS STEM

Catalog Number	01.18.130
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	05/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision for stem loosening, the patient had pain, at about 5 years and 11 months post primary, the surgeon revised the stem and head.The surgery was completed successfully.The stem was reported as undersized.
Additional Manufacturer Narrative
Batch review performed on 16 may 2024: lot 175311: (b)(4) items manufactured and released on 20-dec-2017.Expiration date: 2022-12-11.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported event during the period of review.Clinical analysis performed by medical affairs department: a tha revision surgery was performed 6 years after the primary implant.The patient had complained of pain and performed a follow-up x-ray discovering loosening of the stem.Additionally, undersizing of the stem is reported as a cause of pain.The available x-ray image confirms this diagnosis, showing a mobilization of the stem (which is undersized) with a radiolucency line on the proximo-lateral aspect of the stem and the distal stem shifted towards the lateral cortical of the femur.Additionally, bone reabsorption of the greater trochanter and distal cortical thickening are visible.Aseptic loosening is a possible literature described complication after primary cementless hip arthroplasties and causes are often unknown.The specific reason of this failure cannot be determined, however the undersizing of the stem may have contributed.

• Brand Name: STEM: AMISTEM H HA COATED STD STEM SIZE 0
• 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 19466538
• Report Number: 3005180920-2024-00395
• Device Sequence Number: 3566529
• Product Code: LZO
• UDI-Device Identifier: 07630030804069
• UDI-Public: 07630030804069
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/05/2024

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: 12/11/2022
• Device Catalogue Number: 01.18.130
• Device Lot Number: 175311
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2024
• Initial Report FDA Received Date: 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/20/2017
• 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: Female