MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H, HA COATED STEM SIZE 4 STD; CEMENTLESS FEMORAL STEM

Catalog Number 01.18.134

Device Problem Mechanical Problem (1384)

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

Event Date 08/23/2017

Event Type  Injury  

Manufacturer Narrative

On 15 september 2017 the medical affairs performed a clinical evaluation and commented as follows: one year after primary cementless tha the femoral stem was found to have subsided.Patient details (age, weight, activity levels, post-operative behaviour) are not known.We don't know when the subsidence took place; looking at the x-rays provided, in spite of the poor image quality, osseointegration is visible along the stem, and it is confirmed by the fact that the surgeon could not retrieve the stem at reoperation.Therefore, we should conclude that the stem subsided initially, probably because of insufficient primary stability/press-fit, and then found a stable position.Restoration of correct articular geometry by head/liner exchange has been performed and should allow good performance from now on.The cause of subsidence should not be ascribed to a deficient device.Batch review performed on 18 september 2017.Lot 155657: (b)(4) items manufactured and released on 04 february 2016.Expiration date: 2021-01-20.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 pain.The surgeon determined the stem had subsided.The surgeon tried to remove the stem but was not able so it was left in place.The surgeon swapped the head and liner.The surgery was completed successfully.

• Brand Name: AMISTEM H, HA COATED STEM SIZE 4 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
• MDR Report Key: 6878306
• MDR Text Key: 86702302
• Report Number: 3005180920-2017-00526
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030804106
• UDI-Public: 07630030804106
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 09/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/20/2021
• Device Catalogue Number: 01.18.134
• Device Lot Number: 155657
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/23/2017
• Initial Date FDA Received: 09/20/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/04/2016
• 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: 57 YR