MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM C CEMENTED LAT STEM SIZE 6; CEMENTED HIP STEM

Model Number	01.18.106
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	06/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2023.Lot 2001467: (b)(4) items manufactured and released on 28-may-2020.Expiration date: 2025-05-18.No anomalies found related to the problem.To date, 3 items of the same lot have been sold with no similar reported case during the period of review.
Event or Problem Description
At about 2 months after the primary, the patient came in reporting pain due to a loose stem and the cause is unknown.The surgeon revised the stem, head and liner.The surgery was completed successfully.

• Brand Name: STEM: AMISTEM C CEMENTED LAT STEM SIZE 6
• Common Device Name: CEMENTED HIP STEM
• 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: 17349970
• Report Number: 3005180920-2023-00514
• Device Sequence Number: 17509558
• Product Code: LZO
• UDI-Device Identifier: 07630030803840
• UDI-Public: 07630030803840
• 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: 2023
• Device Explanted Year: 2023
• 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): 07/19/2023

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: 05/18/2025
• Device Model Number: 01.18.106
• Device Catalogue Number: 01.18.106
• Device Lot Number: 2001476
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2023
• Initial Report FDA Received Date: 07/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/28/2020
• 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: 71 YR
• Patient Sex: Female
• Patient Weight: 85 KG
• Patient Race: White