MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM P AMISTEM-P STD STEM SIZE 5; HIP STEM CEMENTLESS

Model Number	01.18.405
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20 july 2021: lot 2000062: (b)(4) items manufactured and released on 05-may-2020.Expiration date: 2025-apr-22.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
Event or Problem Description
Revision surgery 6 months after primary for stem loosening.The surgery was completed successfully.
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director few months after primary cementless thr, the patient feels a sudden pain and the stem needs to be removed.It appears from the examens performed that the possibility of an infection has not been ruled out.In fact, in the radiographic image available, a thick radiolucent area is clearly visible in the proximal-medial area of the stem, which could indicate a problem occurred during preparation or, more likely, a subsequent infection.We have no other explanation to offer for such a rapid and sudden loss of mechanical stability, which is extremely unusual if not exceptional.Preliminary investigation performed by r&d project manager.During the analysis of the photos provided it is evaluated that some blood residuals are present on the stem body.Looking at the ha coating it is visible that the ha coating is present on the proximal part of the stem, while it has been absorbed by patient bone in the distal part (even if some ha residuals are present also on the distal stem).The presence of the ha coating on the proximal part of the stem body is unexpected, meaning that the stem was not correctly osseointegrated with the patient bone (6 months of implantation).This should be the possible cause of the reported patient pain.Some scratches and signs are present on the neck part of the stem, probably due to the revision surgery.It is not possible to determine the root cause of the incorrect stem osteointegration.

• Brand Name: STEM: AMISTEM P AMISTEM-P STD STEM SIZE 5
• Common Device Name: HIP STEM CEMENTLESS
• 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: 12331235
• Report Number: 3005180920-2021-00656
• Device Sequence Number: 14624361
• Product Code: LZO
• UDI-Device Identifier: 07630040720045
• UDI-Public: 07630040720045
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/09/2021

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: 04/22/2025
• Device Model Number: 01.18.405
• Device Catalogue Number: 01.18.405
• Device Lot Number: 2000062
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2021
• Supplement Date Received by Manufacturer: 07/19/2021; 07/19/2021
• Initial Report FDA Received Date: 08/17/2021
• Supplement Report FDA Received Date: 09/22/2021; 11/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/05/2020
• 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: 58 YR
• Patient Sex: Male
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic