MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H, HA COATED STEM SIZE 3 LAT; CEMETLESS FEMORAL STEM

Catalog Number 01.18.143

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Joint Disorder (2373)

Event Date 11/18/2016

Event Type  Injury  

Manufacturer Narrative

On 16 december 2016 the medical affairs director performed a clinical evaluation and commented as follows: loosening of femoral stem in cementless tha 5 years after primary.The loosening is macroscopic, and it is strikingly evident even in the low-quality x-rays.Also, the postoperative image, again very low quality, does not show any evident implantation mistake.It is worth noting that such findings are rather rare and two of them have been reported in the same week by the same surgeon, in both cases an amistem h (not same size) implanted 5 years before.Unfortunately no conclusion can be drawn on this case with the information at hand.Batch review performed on 27 december 2016.(b)(4).

Event Description

Stem revision due to aseptic loosening.The revision surgery was completed successfully.

• Brand Name: AMISTEM H, HA COATED STEM SIZE 3 LAT
• Type of Device: CEMETLESS 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: 6215344
• MDR Text Key: 63615908
• Report Number: 3005180920-2016-00691
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K093944
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2016
• Device Catalogue Number: 01.18.143
• Device Lot Number: 110571
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/01/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/04/2011
• 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: 65 YR
• Patient Weight: 94