MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM C 01.18.155 CEMENTED STD STEM SIZE 5; CEMENTED STEM

Model Number	01.18.155
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 31 january 2022: lot 1909794: (b)(4) items manufactured and released on 09-mar-2020.Expiration date: 2025-02-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Other device involved: batch review performed on 31 january 2022.Mectacer 01.29.210 biolox delta ceramic ball head 12/14 ø 36 size l + 4 (k112115) lot 2100273: (b)(4) items manufactured and released on 05-may-2021.Expiration date: 2026-04-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The patient came in reporting pain and instability due to a leg length discrepancy.The surgeon revised the stem and head 2 months after primary.The surgery was completed successfully.

• Brand Name: AMISTEM C 01.18.155 CEMENTED STD STEM SIZE 5
• Common Device Name: CEMENTED 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: 13440314
• Report Number: 3005180920-2022-00060
• Device Sequence Number: 2046164
• Product Code: LZO
• UDI-Device Identifier: 07630030804304
• UDI-Public: 07630030804304
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• 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): 02/03/2022

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: 02/25/2025
• Device Model Number: 01.18.155
• Device Catalogue Number: 01.18.155
• Device Lot Number: 1909794
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2022
• Initial Report FDA Received Date: 02/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/09/2020
• 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 Sex: Unknown