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

Catalog Number 01.18.145

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Pain (1994)

Event Date 04/18/2016

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2016 the (b)(6) performed a clinical evaluation and commented as follows: stem revision in tha less than two years after primary in a very tall and rather heavy patient.In the postoperative image, the stem does not seem to fill well the proximal femur, the reasons for this are unknown.Signs of proximal loosening are visible in the pre-revision x-ray.Also the screw protruding in the abdomen may be an additional source of pain, or it may be completely silent and harmless.There is no reason to suspect that the femoral loosening was caused by a faulty device.Batch review performed on 20 may 2016.Lot 132646: (b)(4) items manufactured and released on 08 august 2013.Expiration date: 2018-06-30.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.On 23 may 2016 the r&d project manager visually inspected the retrieved explant with the following comments: observing the femoral stem no particular sign can be noted, except on the neck: such signs were probably caused during the removal phase.Bone is present in the anterior and posterior surface of the stem, mainly on the distal part.It is not possible from the inspection of the implants determine the root cause of the event.

Event Description

The patient came to the surgeon because of pain.After taken the x-rays, the surgeon saw there was loosening of the amistem.Revision of the stem was done and it went well.

Manufacturer Narrative

On 22 july 2016 t was prepared a final report with the information already collected and submitted in the initial report.On 25 july 2016 it was sent to the initial reporter and the case was closed.

• Brand Name: AMISTEM H, HA COATED STEM SIZE 5 LAT
• 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: 5673085
• MDR Text Key: 45756866
• Report Number: 3005180920-2016-00240
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 08/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: 01.18.145
• Device Lot Number: 132646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2013
• 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: 59 YR
• Patient Weight: 104