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

Model Number	01.18.131
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	03/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Bach review performed on 27.04.2021: lot 170003: (b)(4) items manufactured and released on 18-may-2017.Expiration date: 2022-05-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Corrected data: on the 27 april 2021 this mdr was sent to the fda test webtrader (https://esgtest.Fda.Gov) for error.Today 9 september 2021 we recognized the error and sent the mdr to fda production webtrader (https://esg.Fda.Gov).
Event or Problem Description
3 years and 8 months after the primary surgery the patient came in reporting pain due to a subsided stem and the cause of the subsided stem is unknown.The surgeon revised the stem and head and the surgery was completed successfully.

• Brand Name: AMISTEM H 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
• MDR Report Key: 12438431
• Report Number: 3005180920-2021-00335
• Device Sequence Number: 14397687
• Product Code: LZO
• UDI-Device Identifier: 07630030804076
• UDI-Public: 07630030804076
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• 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): 09/08/2021

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: 05/07/2022
• Device Model Number: 01.18.131
• Device Catalogue Number: 01.18.131
• Device Lot Number: 170003
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 09/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention