MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H CEMENTLESS STEM SIZE 8 STD; CEMENTLESS FEMORAL STEM

Catalog Number 01.18.138

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Code Available (3191)

Event Date 12/03/2015

Event Type  Injury  

Manufacturer Narrative

On dec, 3rd 2015 we were informed that the explants are not available.Batch review performed on 21 december 2015: (b)(4).

Event Description

Revision due to aseptic loosening of the stem.

Manufacturer Narrative

The medical affairs director performed a clinical evaluation and commented as follows: aseptic loosening 3 years after primary implantation.A very large stem and a rather large cup were implanted in a below-average-sized man.The femur shown rather thin cortices and some ectopic ossifications are also visible.The stem found stability and fixation in the distal part and the proximal femur got less dense and probably less mechanically viable.The root cause for failure cannot be determined positively.On 02 march 2016 it was prepared a final report with the information already submitted in the initial report and here above.On 03 march 2016 the report was sent to the initial reporter and the case was closed.

• Brand Name: AMISTEM H CEMENTLESS STEM SIZE 8 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: 5318828
• MDR Text Key: 34133567
• Report Number: 3005180920-2015-00358
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 03/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Catalogue Number: 01.18.138
• Device Lot Number: 114057
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/03/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/19/2012
• 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: 72 YR
• Patient Weight: 77