MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H 01.18.130 HA COATED STD STEM SIZE 0; HIP COATED STD STEM

Model Number 01.18.130

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Insufficient Information (4580)

Event Date 06/23/2022

Event Type  Injury  

Event Description

Revision surgery was performed 3 years and 4 months after primary surgery due to stem loosening.Stem and head revised successfully.

Manufacturer Narrative

Batch review performed on 7 july 2022: lot 160780: (b)(4) items manufactured and released on 20-may-2016.Expiration date: 2021-may-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot + 3 pieces resterilized have been sold with no similar reported event during the period of review.Clinical evaluation performed by medical affairs department: stem revision performed 3 years and 4 months after primary cementless total hip arthroplasty, according to report, due to stem loosening.In the radiographic image provided, signs of stress shielding are visible, and a slightly shortened leg, or perhaps subsidence of the stem secondary to loosening.In the pre-revision x-ray the position of the stem is suboptimal but we cannot determine if it evolved into such condition.The low quality of the images provided does not allow a more thorough examination; in the lateral view a diaphyseal mark resembling a bone lesion can be detected but it could be an artefact.

Manufacturer Narrative

Visual inspection performed by r&d project manager during the analysis, it is evaluated that almost all ha coating on the stem body has been absorbed by patient bone as expected.Some ha residuals are present on the shoulder part.Some signs and scratches are present on the neck part due to revision surgery.It is not possible to determine the root cause of the reported event.Note: follow-up was sent 12 days late due to human error.

• Brand Name: STEM: AMISTEM H 01.18.130 HA COATED STD STEM SIZE 0
• Type of Device: HIP COATED STD 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: 15075383
• MDR Text Key: 296312446
• Report Number: 3005180920-2022-00547
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030804069
• UDI-Public: 07630030804069
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup
• Report Date: 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/08/2021
• Device Model Number: 01.18.130
• Device Catalogue Number: 01.18.130
• Device Lot Number: 160780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 06/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2016
• 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 Sex: Female
• Patient Weight: 85 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American