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
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery was performed 3 years and 4 months after primary surgery due to stem loosening.Stem and head revised successfully.
Additional 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.
Additional 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
• Common Device Name: 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
• Report Number: 3005180920-2022-00547
• Device Sequence Number: 20162225
• Product Code: LZO
• UDI-Device Identifier: 07630030804069
• UDI-Public: 07630030804069
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2022

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2022
• Supplement Date Received by Manufacturer: 06/23/2022
• Initial Report FDA Received Date: 07/21/2022
• Supplement Report FDA Received Date: 09/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 85 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American