MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM C CEMENTED LAT STEM SIZE 1; HIP CEMENTED STEM

Model Number	01.18.101
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Calcar fracture occurred during surgery.The surgery was successfully completed by fixing the bone fracture.The bone quality is weak.
Additional Manufacturer Narrative
Batch review performed on 15 may 2023: lot 2204010: (b)(6) items manufactured and released on 23-june-2022.Expiration date: 2027-06-07.No anomalies found related to the problem.To date, (b)(6) items of the same lot have been sold without any similar reported event during the period of review.Clinical evaluation performed by medacta medical affairs manager: according to report, calcar fracture was confirmed during surgery.The surgery was successfully completed after fixing with nespron cable.The bone quality is weak.Intraoperative femoral fractures are known possible adverse events of total hip replacements, described and quantified in literature.They mainly depend on bone morphology and mechanical properties.In this case, there is no reason to suspect a malfunctioning device.

• Brand Name: AMISTEM C CEMENTED LAT STEM SIZE 1
• Common Device Name: HIP CEMENTED STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 17097685
• Report Number: 3005180920-2023-00407
• Device Sequence Number: 7826309
• Product Code: LZO
• UDI-Device Identifier: 07630030803796
• UDI-Public: 07630030803796
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 09/06/2023

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 Model Number: 01.18.101
• Device Catalogue Number: 01.18.101
• Device Lot Number: 2204010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2023
• Initial Report FDA Received Date: 06/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/23/2022
• 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: Other
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian