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

Model Number 01.18.133

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/13/2020

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 13 march 2020 lot 145408: (b)(4) items manufactured and released on 09-oct-2014.Expiration date: 2019-08-31.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event since 2016.Preliminary investigation performed by r&d project manager implant covered in biological fluids, from preliminary visual investigation it is not possible to determine failure root cause.Clinical evaluation performed by medical affairs director hip revision surgery performed 5 years after total hip arthroplasty.No information concerning patient age, activity status and presence of comorbidities is available.Radiographic image provided shows the presence of signs of stress shielding and acetabular component looks slightly vertical.The reason of this position is not known: this may be due to particular patient anatomy and introperative conditions that cannot be assessed on a single postsurgical radiograph.No conclusion can be drawn on the basis of available information.

Event Description

Revision surgery performed, 5 years after primary surgery, due to stem loosening.

• Brand Name: STEM: AMISTEM H HA COATED STD STEM 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: 9932107
• MDR Text Key: 186735028
• Report Number: 3005180920-2020-00224
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030804090
• UDI-Public: 07630030804090
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: 01.18.133
• Device Catalogue Number: 01.18.133
• Device Lot Number: 145408
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/10/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/09/2014
• 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