MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H AMIS STEM STD. HAP 12/14 SIZE 3; CEMENTLESS HIP STEM

Model Number 01.18.133

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Pain (1994)

Event Date 05/14/2020

Event Type  Injury  

Manufacturer Narrative

Batch review performed by medacta regulatory affairs department on 26 may 2020: lot 121496: (b)(4) items manufactured and released on 2-jul-2012.Expiration date: 2017-05-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with no other similar reported event since 2016.Clinical evaluation performed by medical affairs director: planned stem revision 6 years and 7 months after primary cementless total hip arthroplasty.No information concerning patient age, general health status or activity level is available.In the radiographic image provided, radiolucent lines are visible and the stem looks slightly undersized.The reason of this choice cannot be assessed on the basis of a single anteroposterior radiographic projection.Aseptic loosening is a possible literature described adverse event after primary cementless hip arthroplasties and causes are often unknown.The reason of this failure cannot be determined.

Event Description

The patient came in reporting pain after 6 years and 7 months after the primary surgery, which was caused by a loose stem.The surgeon plans to revise the stem and the revision surgery has not been scheduled due to the patient anemia.

• Brand Name: STEM: AMISTEM H AMIS STEM STD. HAP 12/14 SIZE 3
• Type of Device: CEMENTLESS HIP 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, switzerland 6874 ; SZ 6874
• MDR Report Key: 10147791
• MDR Text Key: 195015878
• Report Number: 3005180920-2020-00328
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030804090
• UDI-Public: 07630030804090
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Model Number: 01.18.133
• Device Catalogue Number: 01.18.133
• Device Lot Number: 121496
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/14/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/02/2012
• 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): Other