MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H, HA COATED STEM SIZE 6 STD; CEMENTLESS FEMORAL STEM

Catalog Number 01.18.136

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Pain (1994)

Event Date 06/21/2016

Event Type  Injury  

Manufacturer Narrative

On 08 july 2016 the medical affairs director performed a clinical evaluation and commented as follows: stem revision only few months after primary cementless tha.The intraoperative fluoroscopy does not allow any conclusion to be drawn.Stem potting is not clearly visible on this image, and it's rather unusual at few months.Only one hip is visible so no comments can be made on geometry of the hips.An extra-long head was used.There is no reason to suspect that the cause for revision is to be sought in a faulty implant.Batch review performed on 18 july 2016.Lot 141471: (b)(4) items manufactured and released on 24 june 2014.Expiration date: 2019-05-31.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 20 july 2016 it was prepared a final report with the information submitted in this initial report.On 21 july 2016 the report was sent to the initial reporter and the case was closed.

Event Description

The patient came in due to pain.The surgeon determined the pain may be due to a loose stem.The surgeon mentioned the loosening may have been caused by a potted stem.Stem and liner were revised.X-rays are available; explants are not available.

• Brand Name: AMISTEM H, HA COATED STEM SIZE 6 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: 5812194
• MDR Text Key: 50105315
• Report Number: 3005180920-2016-00368
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K093944
• 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: 07/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 01.18.136
• Device Lot Number: 141471
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/22/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/24/2014
• 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: 70 YR