MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMIS AMIS MOBILE 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	06/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27 july 2020: lot 1111566a: (b)(4) item manufactured and released on 17-feb-2017.No anomalies found related to the problem.Additional device involved: amis 01.15.10.0315 amis shoe lot.1657137 or 1751582.Since it is not possible to identify the exact lot number, two batch reviews have been performed.Batch review performed on 27 july 2020: lot 1657137: (b)(4) items manufactured and released on 23-feb-2017.No anomalies found related to the problem.To date, no other similar event has been reported on the lot.Batch review performed on 27 july 2020: lot 1751582: (b)(4) items manufactured and released on 18-may-2017.No anomalies found related to the problem.To date, no other similar event has been reported on the lot.
Event or Problem Description
The patient was diagnosed with an ankle fracture after amis surgery.The fracture was not diagnosed at surgery, it was seen after a couple of days when a hole leg x-ray was made.The surgeon told me, that he thinks that the foot was not properly fixed in the amis shoe, also the patient is very small with a small foot and she was very contract at the hip.He did not need to operate the fracture it is treated conservative.

• Brand Name: AMIS AMIS MOBILE 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: 10372283
• Report Number: 3005180920-2020-00514
• Device Sequence Number: 2889428
• Product Code: LXH
• UDI-Device Identifier: 07630040735773
• UDI-Public: 07630040735773
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/06/2020

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: 1111566A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2020
• Initial Report FDA Received Date: 08/06/2020
• 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