MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM C FEMORAL STEMS; AMISTEM-C STD. SIZE 2

Model Number	01.18.152
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 02 december 2024.Lot 2012819: (b)(4) items manufactured and released on 24-feb-2021.Expiration date: 2026-02-01.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Additional implants revised: ball heads: mectacer 01.29.205 mectacer head biolox delta dia.32 12/14-m (k112115) lot.2109338 batch review performed on 02 december 2024 (b)(4) items manufactured and released on 26-oct-2021.Expiration date: 2026-10-10.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Liner: mpact 01.32.3241hct flat pe hc liner ø32/d (k103721) lot.188505 batch review performed on 02 december 2024.(b)(4) items manufactured and released on 29-nov-2018.Expiration date: 2023-11-12.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported events during the period of review.Root cause: based on the information available no definitive root cause can be established, while there is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.
Event or Problem Description
At about 2 years 9 months after the primary, the patient came in reporting pain and the cause of pain is unknown.The surgeon revised the stem, head and liner and the surgery was completed successfully.

• Brand Name: AMISTEM C FEMORAL STEMS
• Common Device Name: AMISTEM-C STD. SIZE 2
• 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: 20877888
• Report Number: 3005180920-2024-01061
• Device Sequence Number: 20791483
• Product Code: JDI
• UDI-Device Identifier: 07630030804274
• UDI-Public: 07630030804274
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K103189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/09/2024

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: 02/01/2026
• Device Model Number: 01.18.152
• Device Lot Number: 2012819
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/24/2021
• 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