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 Device Operates Differently Than Expected (2913)

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

Event Date 10/11/2017

Event Type  Injury  

Manufacturer Narrative

This is the second revision surgery underwent by the patient.The patient had a primary hip on (b)(6) 2015.On (b)(6) 2016 revision was done due to a potted stem.The stem filled distally but not proximally and thus had radiolucent lines on the greater trochanter.The surgeon went in planning to pull the stem and cementing in another stem, but the surgeon could not get the stem out.The surgeon then put bone and graft in the space proximally and packed it tight.The surgeon revised the head and liner as well.In (b)(6) 2017 the patient came in complaining of pain.On 03 november 2017 the medical affairs performed a clinical evaluation and commented as follows: one year after cementless primary tha the stem found only distal fixation.A revision was attempted but the stem could not be extracted, so the surgeon attempted salvage by impacting bone graft proximally.One more year later, the attempt failed and final revision had to be performed.Aseptic loosening consequent to distal fixation is a possible, literature described adverse event after cementless total hip replacement and reasons are often unknown.In this case, the real cause of the event cannot be determined.Batch review performed on 10 november 2017.Lot 146959: (b)(4) items manufactured and released on 16 february 2015.Expiration date: 2019-12-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold and this is the second similar event reported on the lot.

Event Description

The patient came in complaining of pain.The surgeon determined that the stem had potted.The surgeon revised the stem, 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: 7018026
• MDR Text Key: 91875779
• Report Number: 3005180920-2017-00653
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 01.18.134
• Device Lot Number: 146959
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/12/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/16/2015
• 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