MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM C CEMENTED LAT STEM SIZE 3; CEMENTLESS STEM

Model Number	01.18.103
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23 november 2020: lot 185795: (b)(4) items manufactured and released on 26-oct-2018.Expiration date: 2023-10-16.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.Clinical evaluation performed by medical affairs director: early proximal fracture after hybrid tha in a patient with very thin cortical walls, age unknown, other patient information not provided.The report mention a "possible" trauma.The weak bone is a condition that may jeopardize the outcome of the surgery.We could not find any reason to suspect a faulty device as the cause for this adverse event.
Event or Problem Description
The patient had revision surgery on (b)(6) 2020.However, 2 months after previous surgery, the femur broke probably due to trauma and due to the thinner bone walls.Therefore the surgeon revised the patient again and removed our stem and head implanting competitor's devices.

• Brand Name: STEM: AMISTEM C CEMENTED LAT STEM SIZE 3
• Common Device Name: CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10983869
• Report Number: 3005180920-2020-00899
• Device Sequence Number: 11507023
• Product Code: LZO
• UDI-Device Identifier: 07630030803819
• UDI-Public: 07630030803819
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K103189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/10/2020

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: 10/16/2023
• Device Model Number: 01.18.103
• Device Catalogue Number: 01.18.103
• Device Lot Number: 185795
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2020
• Initial Report FDA Received Date: 12/10/2020
• 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
• Patient Weight: 73