MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM P 01.18.413 AMISTEM-P LAT STEM SIZE 3; FEMORAL COMPONENT

Model Number	01.18.413
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 29 october 2021: lot 1811117: (b)(4) items manufactured and released on 04-apr-2019.Expiration date: 2024-03-19.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 for stem loosening performed 1 year and 3 months after primary.
Additional Manufacturer Narrative
Device returned on december 13, 2021 and analyzed the same day.Visual inspection performed by r&d project manager.During the analysis it is evaluated that the ha coating on the stem body has been completely absorbed by patient bone as expected.The proximal titaniu coating is clearly visible.Some fragments of patient bone are present on the stem body distal part.Some signs and scratches are present on the neck part probably due to revision surgery.It is not possible to determine the root casue of reported complaint.

• Brand Name: STEM: AMISTEM P 01.18.413 AMISTEM-P LAT STEM SIZE 3
• Common Device Name: FEMORAL COMPONENT
• 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: 12758102
• Report Number: 3005180920-2021-00855
• Device Sequence Number: 16971653
• Product Code: LZO
• UDI-Device Identifier: 07630040720120
• UDI-Public: 07630040720120
• 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: 2020
• Device Explanted Year: 2021
• 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): 01/05/2022

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: 03/19/2024
• Device Model Number: 01.18.413
• Device Catalogue Number: 01.18.413
• Device Lot Number: 1811117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2021
• Supplement Date Received by Manufacturer: 10/07/2021
• Initial Report FDA Received Date: 11/07/2021
• Supplement Report FDA Received Date: 01/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2019
• 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: Other
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White