MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H COATED STD SIZE 3; HIP UNCEMENTED STEM

Model Number 01.18.133

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Joint Disorder (2373)

Event Date 07/28/2020

Event Type  Injury  

Manufacturer Narrative

Batch review performed by medacta regulatory affairs department on 5 august 2020: lot 146954: (b)(4) items manufactured and released on 19-jan-2015.Expiration date: 2019-12-31.No anomalies found related to the problem.To date, 99 items of the same lot have been already sold without any other similar reported event since 2016.Clinical evaluation performed by medacta medical affairs manager: femoral component (stem and head) revision performed 5 years after primary cementless total hip arthroplasty in an elderly lady ((b)(6) year old).No information concerning patient general health status and the presence of comorbidities is available.In the radiographic image provided, radiolucent lines and signs of stress shielding are visible.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

Stem mobilization after 5 years and 3 months after the primary surgery.The surgeon revised the stem.The patient felt pain for 2 years before the revision, the stem wasn't integrated.The revision surgery was performed successfully and they put a cemented stem amistem c size 3.The explant came out easily from the femur.

• Brand Name: STEM: AMISTEM H COATED STD SIZE 3
• Type of Device: HIP UNCEMENTED 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: 10425086
• MDR Text Key: 209991963
• Report Number: 3005180920-2020-00530
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030804090
• UDI-Public: 07630030804090
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 08/19/2020

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: 12/31/2019
• Device Model Number: 01.18.133
• Device Catalogue Number: 01.18.133
• Device Lot Number: 146954
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/20/2020
• Initial Date FDA Received: 08/19/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/19/2015
• 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: 83 YR