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

Catalog Number 01.15.10.0190

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 09/19/2018

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 18 october 2018.Lot 1656236: (b)(4) items manufactured and released on 8 march 2018.No anomalies found related to the issue.To date, no similar event on the same lot has been registered.Additional item involved in the event: stem: amis-k 01.20.003 amis-k size 2s1 standard (not registered in us), lot 181278: (b)(4) items manufactured and released on 23 april 2017.Expiration date:2023-04-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Amis 01.15.10.0315 amis shoe lot 1754696: (b)(4) items manufactured and released on 23 february 2018.No anomalies found related to the issue.To date, no similar event on the same lot has been registered.Clinical evaluation performed by medical affairs director: fracture of a femoral condyle was detected after primary tha with cemented femoral stem.The relationship between the fracture and the hip operation is unknown and quite unlikely.We see no possibility that this may have been caused by a faulty device.

Event Description

Femoral condyle bone fracture discovered through the x-rays after hip surgery.It is unknown when the fracture occurred because no x-rays around the knee were taken before the surgery.The patient will be followed-up.

• Brand Name: AMIS MOBILE LEG POSITIONER 2.0 FRAME
• Type of Device: SURGICAL INSTRUMENT FOR HIP SURGERIES
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7984644
• MDR Text Key: 124332463
• Report Number: 3005180920-2018-00801
• Device Sequence Number: 1
• Product Code: LHX
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 01.15.10.0190
• Device Lot Number: 1656236
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/19/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/08/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 88 YR