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

Catalog Number 01.18.132

Device Problems Failure To Adhere Or Bond (1031); Unstable (1667)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/11/2016

Event Type  Injury  

Manufacturer Narrative

On 29 april 2016 the medical affairs director performed a clinical evaluation and commented as follows: according to report, cementless stem loosened after less than 1 year since tha.From the supplied image, no analysis can be done and no conclusion drawn.No allegation of a faulty device has been made.Batch review performed on 10 may 2016.Lot 144466: (b)(4) items manufactured and released on 17 september 2014.Expiration date: 2019-07-31.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.

Event Description

The patient came in complaining of instability.The stem became loose.The surgeon revised the stem, head and liner.The surgery was completed successfully.X-rays are available.Explants are not available.

Manufacturer Narrative

On 07 july 2016 it was prepared a final report with the information already submitted in the initial report.On 12 july 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: 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: 5647011
• MDR Text Key: 44986909
• Report Number: 3005180920-2016-00211
• 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,Followup
• Report Date: 07/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 01.18.132
• Device Lot Number: 144466
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/11/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/17/2014
• 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: 56 YR