MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM C CEMENTED STD STEM SIZE 3; HIP STEM CEMENTED

Model Number	01.18.153
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 1 month after the primary surgery, the patient was operated due to a periprosthetic bone fracture, which was probably generated by the first surgery.The surgeon removed the prosthesis and successfully implanted an amis-k long stem and another 46l endohead.
Additional Manufacturer Narrative
Batch review performed on 27-jul-2022.Lot 2114232: (b)(4) items manufactured and released on 25-jan-2022.Expiration date: 2027-01-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Clinical evaluation performed by medical affairs department.Revision 1 month after primary cemented tha in a elderly patient, due to a periprosthetic fracture.According to report, the fracture might have happened during the first surgery.Intraoperative femoral fractures are known possible adverse events of total hip replacements, described and quantified in literature, made more likely by the advanced age of the patient.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 3
• Common Device Name: HIP STEM CEMENTED
• 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: 15247650
• Report Number: 3005180920-2022-00622
• Device Sequence Number: 14905061
• Product Code: LZO
• UDI-Device Identifier: 07630030804281
• UDI-Public: 07630030804281
• 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: 2022
• Device Explanted Year: 2022
• 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): 08/18/2022

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: 01.18.153
• Device Catalogue Number: 01.18.153
• Device Lot Number: 2114232
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2022
• Initial Report FDA Received Date: 08/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/25/2022
• 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: Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White