MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H, HA COATED STEM SIZE 2 STD; FEMORAL STEM

Catalog Number 01.18.132

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 01/14/2016

Event Type  Injury  

Manufacturer Narrative

Additional information received on 22 january 2016 and includes: revision surgery took place on (b)(6) 2016.As expected, the stem was removed without difficulty because of loosening.Batch review performed on 08 february 2016.(b)(4).On 11 february 2016 the medical affairs director made the following analysis upon checking the x-ray: tha of 2,5 years with clear signs of stress shielding and loosening.This is a possible complication of tha, described in literature.It is not to be ascribed to a defect of the device.The appearance does not resemble a case of osteolytic lesions, rather an evolution or radiolucencies following stress shielding and progressive proximal loss of fixation.On 12 february 2016 the r&d project manager checked the pictures of the explant received, commenting as following: observing the femoral stem no particular sign can be noted, except on the neck: such signs was probably caused during the removal phase.The ha on the surface of the stem seems reabsorbed.No bone can be seen on the surface of the stem, except few bones on the distal posterior one.It is not possible from the inspection of the images determine the root cause of the event.

Event Description

Revision planned, about 1 year and 8 months after surgery, due to stress-shielding in gruen zone 3 and 5 with reabsorption in gruen zone 1 and 7 (possible stem loosening).

Manufacturer Narrative

On 14 april 2016 it was prepared a final report with the information already submitted in the initial report.On 27 april 2016 the report was sent to the initial reporter and the case was closed.

• Brand Name: AMISTEM H, HA COATED STEM SIZE 2 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: 5434222
• MDR Text Key: 38137841
• Report Number: 3005180920-2016-00037
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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
• Report Date: 05/13/2016

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: 01/31/2018
• Device Catalogue Number: 01.18.132
• Device Lot Number: 130044
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/14/2016
• Initial Date FDA Received: 02/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/13/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/08/2013
• 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: 63 YR
• Patient Weight: 68