MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H, HA COATED STEM SIZE 5 STD; FEMORAL STEM

Catalog Number 01.18.135

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem Bone Fracture(s) (1870)

Event Date 01/22/2016

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 16 february 2016: (b)(4).On 19 feb 2016 the medical affairs director made the following analysis: according to report, the surgeon asked for a dimensional verification of the stem dimensions, because he surmised that the difficulties he had to drive the stem down were due to a dimensional problem.This is a technical aspect, which will be investigated technically on the returned device.Clinically speaking, several situations could lead to the described contingency without requiring a real dimensional mismatch, such as insufficient penetration of the broach (according to report, trial reduction with broach and trial head was not performed), inaccurate rotational positioning of the final stem versus broached cavity, varus or valgus positioning of the stem.Of course none of these possible situations can be verified.For this reason, the clinical investigation cannot be expected to draw any conclusion.

Event Description

The surgeon implanted an amistem-h # 5 and he noticed that protruded of 1 cm.He decided to remove it causing the femur fracture.The fracture was then treated with a cerclage and replacing the stem with a cemented amistem.

Manufacturer Narrative

On 23 march 2016 the (b)(4) project manager analysed the returned implants.Observing the femoral stem some scratches can be noted, also on the neck: such signs was probably caused during the removal phase.The ha on the surface of the stem is almost totally present.On the femoral head some signs can be seen probably caused during the removal phase.The stem will be dimensionally analyzed by the cq department.With the information we have till now, it is not possible to determine the root cause of the event.

Manufacturer Narrative

On 20 april 2016 the quality control manager performed a metrological analysis of the stem involved in this complaint and commented as follows: the documental investigation confirms that the device has been produced according to the specification valid at the time of manufacturing.On 20 april 2016 it was prepared a final report with the information submitted in this report and in the previous ones.On 20 may 2016 the report was sent to the initial reporter and the case was closed.

• Brand Name: AMISTEM H, HA COATED STEM SIZE 5 STD
• Type of Device: 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: 5446939
• MDR Text Key: 38557309
• Report Number: 3005180920-2016-00055
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K093944
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/20/2016

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: 07/21/2020
• Device Catalogue Number: 01.18.135
• Device Lot Number: 153128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/22/2016
• Initial Date FDA Received: 02/19/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/24/2016; 05/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2015
• 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: 68 YR