MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H, HA COATED STEM SIZE 1 LAT; CEMENTLESS FEMORAL STEM

Catalog Number 01.18.141

Device Problem Failure To Adhere Or Bond (1031)

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

Event Date 10/12/2016

Event Type  Injury  

Manufacturer Narrative

Only right side implants were involved (primary surgery bilateral), the invoice did not state which stem/head were implanted in right hip.On 21 october 2016 the initial reporter added that: i was not able to get the explants to return them, and i have asked the hospital but they do not have record of which specific lot number the implant was.On 04 november 2016 the medical affairs director performed a clinical evaluation and commented as follows: stem revision in a cementless tha after 5 years.Implants seem to be correctly positioned; only one projection is available so no estimation of correct sizing can be made from the images.Orientation, in the one projection available, appears to be correct.The contralateral hip, identical, seems to be well performing after the same period of time.The cause for this loosening cannot be identified with the information available.Batch review made on 08 november 2016 on both the lots of stems implanted (same code) in the same bilateral surgery: (b)(4).

Event Description

The patient has thigh pain.The surgeon stated that the stem was loose.A revision surgery was required.

• Brand Name: AMISTEM H, HA COATED STEM SIZE 1 LAT
• 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: 6095831
• MDR Text Key: 59756788
• Report Number: 3005180920-2016-00581
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• 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 Catalogue Number: 01.18.141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/13/2016
• Was Device Evaluated by Manufacturer?: No
• 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 Weight: 78