MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H, HA COATED STD STEM SIZE 1; HIP CEMENTLESS STEM

Model Number	01.18.131
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	04/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in reporting pain due to a loose stem and the cause is unknown.The surgeon revises the stem and head to another company's products almost 4 years and 2 months after primary.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 06 april 2022: lot 153968: (b)(4) items manufactured and released on 06-nov-2015.Expiration date: 2020-10-14.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event since 2018.

• Brand Name: AMISTEM H, HA COATED STD STEM SIZE 1
• Common Device Name: HIP CEMENTLESS 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: 14304057
• Report Number: 3005180920-2022-00325
• Device Sequence Number: 5026511
• Product Code: LZO
• UDI-Device Identifier: 07630030804076
• UDI-Public: 07630030804076
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/05/2022

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: 10/14/2020
• Device Model Number: 01.18.131
• Device Catalogue Number: 01.18.131
• Device Lot Number: 153968
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2022
• Initial Report FDA Received Date: 05/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/06/2015
• 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