MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM C CEMENTED STD STEM SIZE 4; HIP STEM CEMENTED

Model Number	01.18.154
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	02/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Post-op control x-ray revealed a femoral bone fracture.At 5 days after the primary, the surgeon revised stem, head and liner and the surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2023 lot 2007191: 59 items manufactured and released on (b)(6) 2020.Expiration date: 2025-10-23.No anomalies found related to the problem.To date, 51 items of the same lot have been sold without any similar reported event during the period of review.Clinical evaluation performed by medical affairs department.Revision 5 days after the primary tha due to femoral fracture revealed from a post-op control x-ray.From the poor quality image received, the fracture seems to be of high energy type but the report does not mention any traumatic event.The surgeon revised stem, head and liner and the surgery was completed successfully.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: STEM: AMISTEM C CEMENTED STD STEM SIZE 4
• Common Device Name: HIP STEM CEMENTED
• 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16544240
• Report Number: 3005180920-2023-00142
• Device Sequence Number: 17760255
• Product Code: LZO
• UDI-Device Identifier: 07630030804298
• UDI-Public: 07630030804298
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K103189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted 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): 03/15/2023

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 Expiration Date: 10/23/2025
• Device Model Number: 01.18.154
• Device Catalogue Number: 01.18.154
• Device Lot Number: 2007191
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 03/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/30/2020
• 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 Age: 67 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White