MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MINIMAX CEMENTLESS ANATOMICAL STEM LEFT SIZE 4; CEMENTLESS HIP STEM

Catalog Number 01.13.104L

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 10/13/2018

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 07 november 2018.Lot 122208: (b)(4) items manufactured and released on 04 september 2012.Expiration date: 2017-07-31.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event.Clinical evaluation performed on november 06, 2018 by medical affairs director.5 years after revision hip arthroplasty the femoral stem, which had been left in place at revision, broke off at the neck level.The explants have not been received so they could not be analyzed.From the pictures sent, it appears that the fracture may have started laterally and looks like a fatigue fracture, but of course the documentation is not sufficient for a final assessment.However, the experience shows that this kind of fractures, extremely rare, are almost always caused by a damaged inflicted upon the prosthesis neck during the first revision operation.Often the electrocauter is the cause of such damages.Based on this experience, medacta issued a field safety notice in february 2013, a few months before the first revision operation of this case, warning against accidental implant damage during revision surgery that leaves some components in place.A final decision on the root cause of the failure cannot be expressed because the explants were not returned.Preliminary investigation performed by r&d product manager on november 05, 2018.Implant shows fatigue fracture of femoral neck and several unknown marks and pits on the neck region.Deep scratch on the stem due to extraction.Visual investigation of the component is necessary to determine failure root cause.Since the patient underwent head, liner and shell revision in (b)(6) 2013 it is possible that the neck failure could be related to possible damages due to electrosurgical unit.If the electrode comes into contact with the femoral stem, it may introduce surface cracks that with time may lead to fracture on the interested region.In april 2013 medacta informed all clients on the possible risks of revision surgical procedure.

Event Description

We were informed on (b)(4) 2018 that on (b)(6) 2018 the patient went to the hospital since he heard a noise and the articulation is not stable.Patient was revised due to hip luxation in 2013, cup, head and liner were removed.In 2018 the patient was revised again due to neck stem breakage.Stem and head were revised.

• Brand Name: MINIMAX CEMENTLESS ANATOMICAL STEM LEFT SIZE 4
• Type of Device: CEMENTLESS HIP STEM
• 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: 8045556
• MDR Text Key: 126358485
• Report Number: 3005180920-2018-00860
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030803215
• UDI-Public: 07630030803215
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K170845
• 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: 11/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Catalogue Number: 01.13.104L
• Device Lot Number: 122208
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/08/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/04/2012
• 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: 54 YR
• Patient Weight: 100