MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM-P STD STEM SIZE 2; HIP CEMENTLESS STEM

Catalog Number	01.18.402
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	03/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 31.03.2021: lot 2001464: (b)(4) items manufactured and released on 07.07.2020.Expiration date: 2025-06-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Clinical evaluation performed by medacta medical affairs manager: femoral component revision performed 4 months after primary cementless total hip arthroplasty.No information concerning patient age, general health status and the presence of comorbidities is available.In the radiographic image provided, radiolucent lines are visible.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.Preliminary investigation performed by medacta r&d hip project manager: looking at the image of the explanted stem it is visible that the whole ha on the stem body seems to be completely absorbed as expected.On the taper part a big scratch is present on the bottom part and it is reasonably to assert that it is due to the revision surgery.It is not possible to determine the root cause of the reported loosening.
Event or Problem Description
Revision surgery 4 months after the primary surgery for stem mobilization.

• Brand Name: AMISTEM-P STD STEM SIZE 2
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11700205
• Report Number: 3005180920-2021-00316
• Device Sequence Number: 14327565
• Product Code: LZO
• UDI-Device Identifier: 07630040720014
• UDI-Public: 07630040720014
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/21/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2025
• Device Catalogue Number: 01.18.402
• Device Lot Number: 2001464
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 04/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention