MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM-P COLLARED AMISTEM-P COLLARED LAT STEM SIZE 7; CEMENTLESS STEM

Model Number	01.18.447
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	07/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 1 year and 1 month after the primary surgery, the patient came in reporting pain due to a loose stem and the cause of the loose stem is unknown.The surgeon revised the medacta stem and head with competitor components and revised the medacta liner with a medacta liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 25-jul-2021 lot 188034: 41 items manufactured and released on 07-dec-2018.Expiration date: 2023-11-26.No anomalies found related to the problem.To date, 18 items of the same lot have been sold with no similar reported case during the period of review.

• Brand Name: STEM: AMISTEM-P COLLARED AMISTEM-P COLLARED LAT STEM SIZE 7
• Common Device Name: 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: 15247454
• Report Number: 3005180920-2022-00624
• Device Sequence Number: 6341302
• Product Code: LZO
• UDI-Device Identifier: 07630040720366
• UDI-Public: 07630040720366
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K173794
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/18/2022

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: 11/26/2023
• Device Model Number: 01.18.447
• Device Catalogue Number: 01.18.447
• Device Lot Number: 188034
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2022
• Initial Report FDA Received Date: 08/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/07/2018
• 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