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

Catalog Number 01.18.132

Device Problem Failure To Adhere Or Bond (1031)

Patient Problems Pain (1994); Joint Disorder (2373)

Event Date 10/13/2016

Event Type  Injury  

Manufacturer Narrative

On 04 november 2016 the medical affairs director performed a clinical evaluation and commented as follows: stem loosening in cementless tha in an elderly female patient after almost 6 years.Only one projection, very poor quality x-ray is available and no conclusion can be drawn from the supplied information.The reason for this loosening remains unknown; there is no specific indication of a faulty device being responsible.Batch review performed on 08 november 2016.(b)(4).

Event Description

The patient came in complaining of hip pain.The surgeon noticed the stem was loose.The cause of the loosening is unknown.There is no report of trauma.The surgeon revised the stem, head and liner.The surgery was completed successfully.

• 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: 6095834
• MDR Text Key: 59758447
• Report Number: 3005180920-2016-00583
• 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: 11/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2015
• Device Catalogue Number: 01.18.132
• Device Lot Number: 102754
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/14/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/06/2010
• 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: 89 YR