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	11/03/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery was performed on (b)(6) 2021 due to stem loosening, the stem had and liner were revised.The exact primary date is unknown.
Additional Manufacturer Narrative
Batch review performed on 15 november 2021: lot 173487: (b)(4) items manufactured and released on 10-oct-2017.Expiration date: 2022-09-26.No anomalies found related to the problem.To date, (b)(4) item of the same lot has been sold.Preliminary investigation performed by medacta r&d hip project manager: during the analysis it is evaluated that the ha on the stem body has been completely absorbed by patient bone as expected.Some signs and scratches are present on the neck part probably due to revision surgery.It is not possible to determine the root cause of the reported stem loosening.

• 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
• 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: 12859341
• Report Number: 3005180920-2021-00939
• Device Sequence Number: 4093578
• Product Code: LZO
• UDI-Device Identifier: 07630030804076
• UDI-Public: 07630030804076
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• 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): 11/23/2021

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: 09/26/2022
• Device Model Number: 01.18.131
• Device Catalogue Number: 01.18.131
• Device Lot Number: 173487
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/10/2017
• 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