MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM C CEMENTED STD STEM SIZE 8; HIP STEM CEMENTED

Model Number	01.18.158
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	03/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
At 3 days after the primary, the patient came in reporting pain due to a periprosthetic fracture and the cause is unknown.The surgeon cabled the fracture and revised the stem and head.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 07 march 2022.Lot 1907526: (b)(4) items manufactured and released on 11-feb-2020.Expiration date: 2025-01-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.

• Brand Name: STEM: AMISTEM C CEMENTED STD STEM SIZE 8
• 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: 13964413
• Report Number: 3005180920-2022-00214
• Device Sequence Number: 4176925
• Product Code: LZO
• UDI-Device Identifier: 07630030804335
• UDI-Public: 07630030804335
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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): 03/31/2022

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 Expiration Date: 01/27/2025
• Device Model Number: 01.18.158
• Device Catalogue Number: 01.18.158
• Device Lot Number: 1907526
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2022
• Initial Report FDA Received Date: 03/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/11/2020
• 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 Sex: Unknown