MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: MINIMAX CEMENTLESS ANATOMICAL STEM LEFT SIZE 2; HIP STEM CEMENTLESS

Model Number	01.13.102L
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	03/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in reporting pain and the cause of the pain was unknown.At 2 weeks form primary the surgeon determined that the patients stem was undersized and the femur bone fractured.The surgeon revised the stem and head.The surgery was completed successfully.
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs department.Postoperative femoral fracture, few weeks after cementless tha.The patient came in reporting pain.From the radiographic image it is visible a bone fracture in the medial area of the femur.The reason of the fracture is unknown, no specific traumatic event is reported.Often the preparation of the femoral bone by broaches may weaken locally the bone and when load is applied a fracture may occur.Both stem and head were revised.No reason to suspect that this event is due to a faulty device.Batch review performed on 31 march 2022: lot 150554c: (b)(4) items manufactured and released on 19-june-2018.Expiration date: 2023-06-06.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Original lot.Lot 150554: (b)(4) items manufactured and released on 12-may-2015.Expiration date: 2020-03-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold (resterilized devices considered) without any similar reported event either on the other resterilized devices of this lot.

• Brand Name: STEM: MINIMAX CEMENTLESS ANATOMICAL STEM LEFT SIZE 2
• Common Device Name: HIP STEM CEMENTLESS
• 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: 14165859
• Report Number: 3005180920-2022-00284
• Device Sequence Number: 12205116
• Product Code: LZO
• UDI-Device Identifier: 07630030803178
• UDI-Public: 07630030803178
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K170845
• 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): 04/21/2022

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: 06/06/2023
• Device Model Number: 01.13.102L
• Device Catalogue Number: 01.13.102L
• Device Lot Number: 150554C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2022
• Initial Report FDA Received Date: 04/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/19/2018
• 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