MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMIS LEG POSITIONER 2.0 FRAME; INSTRUMENT FOR HIP SURGERY

Model Number	01.15.10.0190
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 29 january 2021: lot 1112087aa: (b)(4) item manufactured and released on 15-sept-2015.No anomalies found related to the problem.To date, no other similar events have been reported since 2017.
Event or Problem Description
During the amis surgery, at hip reduction phase the patient tibia and fibula fractured.The surgeon fixed the fracture and finished the surgery.The patient (female,(b)(6)) was osteophorotic and had an intestine tumor (under chemi treatment).

• Brand Name: AMIS LEG POSITIONER 2.0 FRAME
• Common Device Name: INSTRUMENT FOR HIP SURGERY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11341588
• Report Number: 3005180920-2021-00124
• Device Sequence Number: 11599917
• Product Code: LXH
• UDI-Device Identifier: 07630040735773
• UDI-Public: 07630040735773
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 02/18/2021

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: 01.15.10.0190
• Device Catalogue Number: 01.15.10.0190
• Device Lot Number: 1112087AA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2021
• Initial Report FDA Received Date: 02/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 82 YR
• Patient Weight: 50