MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM-P COLLARED 01.18.432 AMISTEM-P COLLARED STD STEM SIZE 2; HIP AMISTEM-P COLLARED STD STEM

Catalog Number	01.18.432
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	10/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had pain due to a subsided stem and the cause of the subsided stem is unknown.At about 13 days from primary the surgeon revised the stem and head and the surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 30 october 2023: lot 2302647: 40 items manufactured and released on 24-may-2023.Expiration date: 2028-05-03.No anomalies found related to the problem.To date, 30 items of the same lot have been sold without any similar reported event in the period of review.

• Brand Name: STEM: AMISTEM-P COLLARED 01.18.432 AMISTEM-P COLLARED STD STEM SIZE 2
• Common Device Name: HIP AMISTEM-P COLLARED STD 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: 18204617
• Report Number: 3005180920-2023-00901
• Device Sequence Number: 15056543
• Product Code: LZO
• UDI-Device Identifier: 07630040720212
• UDI-Public: 07630040720212
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173794
• 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): 11/24/2023

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 Catalogue Number: 01.18.432
• Device Lot Number: 2302647
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2023
• Initial Report FDA Received Date: 11/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/24/2023
• 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: Female