MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MASTERLOC CEMENTLESS TI COATED STEM #SIZE 10 STD; CEMENTLESS FEMORAL STEM

Catalog Number 01.39.010

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem Joint Disorder (2373)

Event Date 10/04/2016

Event Type  Injury  

Manufacturer Narrative

On 21 october 2016 the medical affairs director performed a clinical evaluation and commented as follows: the reason for reoperation is protrusion of the femoral stem from the bone, causing pain.The situation is not visible from standard ap x-ray.The patient's femur appears somewhat bowed, this circumstance may have facilitated the occurrence of the adverse event.No reason to suspect a malfunctioning device.Batch review performed on 03 november 2016.Lot 162766: (b)(4) items manufactured and released on 14 june 2016.Expiration date: 2021-06-01.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.

Event Description

The patient came in complaining of pain.The stem protruded out of the femoral canal.The surgeon revised the stem and head.The surgery was completed successfully.

• Brand Name: MASTERLOC CEMENTLESS TI COATED STEM #SIZE 10 STD
• Type of Device: CEMENTLESS FEMORAL STEM
• 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, 6874 ; SZ 6874 ; 91 6966060
• MDR Report Key: 6075915
• MDR Text Key: 59056977
• Report Number: 3005180920-2016-00562
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K151531
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/03/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2021
• Device Catalogue Number: 01.39.010
• Device Lot Number: 162766
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/04/2016
• Initial Date FDA Received: 11/03/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/14/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR